CHAPTER 1

INTRODUCTION

Contact lens is an artificial device whose front surface substitutes the anterior
surface of the cornea. It is used for refractive errors correction as well as cosmetic
purpose. They can be used for therapeutically in several corneal diseases. 1Contact
lenses interact with the ocular surface via the tear film, the corneal epithelium,
and the conjunctival epithelium. A contact lens must allow sufficient oxygen flow
to maintain corneal homeostasis, tear film stability and aerobic
metabolism.2Contact lenses can be classified by the nature of the material from
which they are made, by their wearing schedule, by their purpose, or by their
design.Nature of the material is Hard, Rigid gas permeability, Hydrogel and
Hybrid.3 Contact lenses can be grouped in three main categories based on their
composition: soft, rigid, and hybrid contact lenses. Rigid lenses were the first to
be introduced in the form of glass lenses. Rigid contact lenses are used for
astigmatism and corneal irregularities. Soft lenses are made of hydrogels that is
water-containing polymers, which allow better comfort and higher flexibility than
rigid lenses. Soft lenses are 2–3 mm larger than the cornea, with a diameter of
14.5 mm. They are produced solely in the form of corneal lenses, and they lay on
the cornea. Soft lens materials may be hydrogels (low-Dk materials) or silicone
hydrogels (high-Dk materials).Hydrogel lenses were first produced by
polymerization of HEMA, leading to a water content of the 40%. 2Hydrophilic soft
contact lenses are classified according to:Method of manufacture. They are spin-
cast contact lenses that are lathed, molded, and mixed (one surface lathed and one
surface spin- cast).Water content. Low, medium, and high water content lenses
are, respectively, 38%, 55%, and 75% water. Permeability: medium and high
permeability, Dk less than or greater than 50, respectively. Transmissibility: The
transmissibility to oxygen will depend on the Dk of the primary material and the
thickness of the lens, as in rigid gas permeable lenses. U.S,Food and Drug
Administration(FDA)classificationgroup1:Lowwater(lessthan50%watercontent)n

1
onionicpolymers.Group2:Highwater(greaterthan50%watercontent)non-
ionicpolymers.Group3:Lowwater(lessthan50%watercontent)ionicpolymersgroup4
:High water (greaterthan50%watercontent) ionic polymers (highest affinity for
tear protein deposition in group 4 lenses), Color, Clear lenses,Light blue or green
visibility tinted lenses that do not alter eye color Cosmetic contact lenses:
principal function is to alter the color of the iris or the appearance of the
cornea,Length of use,Daily use,Extended use (worn during both waking hours and
sleep),Sporadic use (occasional only).The clinician determines the wearing
schedule at the time of the clinical evaluation. The wearing schedule is
determined based on the patient’s goals for contact lens wear. Lens life:
disposable versus non disposable contact lenses.The central posterior curve
should be approximately 0.6 to 0.8 mm flatter than the average corneal curvature
measurement. The lens diameter should be approximately 2.0 mm larger than the
horizontal visible iris diameter. Diameter is the determining factor in the
centration of the contact lens. The limbus should remain covered by the lens
during the blink. However, the greater the diameter, the less the movement of the
lens and the greater its adherence. Ideally, the lens should move 0.5 to 1 mm with
the blinkhis type of contact lens was approved by the U.S. Food and Drug
Administration to be discarded after 7 days of extended wear or 14 days of daily
wear. It is currently the most prescribed disposable lens option in the United
States. Patients using their lenses on a daily wear basis need to disinfect their
lenses between uses. It is generally not necessary to add enzyme cleaning to the
lens care regimen for patients replacing their lenses every 1to2 weeks. A new
generation of materials with oxygen permeability (Dk) values greater than 100
has been prescribed in parts of the world since 1999. These lenses are
manufactured from a silicone hydrogel material with a treated surface that is more
hydrophilic and more resistant to deposits. In this type of material, the aqueous
phase functions to promote comfort and movement, while the silicone is
responsible for the high permeability to oxygen. Even though these lenses were
developed for continuous use over a 30-day period, many eye care practitioners
pre- scribe them for daily wear use or recommend that the lenses be removed once

2
weekly for disinfection. Reduced lens handling should result in fewer torn and
microbially contaminated lenses.3 Hybrid contact lenses have a central optical
zone made of RGP material, surrounded by a peripheral fitting zone made of a
silicone hydrogel.2 Contact lens has been used for vision correction all over the
world. There are an estimation that 140 million people worldwide who wear
contact lenses (cls) for refractive error corrections.4 Daily wear (removed daily
and not utilized during sleep).Continuous or extended wear (utilized both during
waking and sleep hours for a specified number of days continuously). These
lenses are generally made from high water content or high DK material Flexible
wear (utilized during the day and occasionally overnight).
Traditional/conventional: replaced annually. Disposable or planned replacement
(discarded after a specified wearing period defined by manufacturer’s guidelines).
Can be disposed of daily, weekly, biweekly, monthly, bimonthly, or quarterly.
Occasional (indicated for occasional use, e.g., athletic or social activities).A
thorough examination of each patient’s history, medical conditions, expectations
and responsibility, refractive needs, and response to trial fitting determines
whether contact lenses are appropriate. The principal indications for contact lens
fitting are as follows.In optical indications Most contact lens wearers fall into this
group. The great majority are myopic with or without astigmatism Medical
indications are keratoconus ,Irregular astigmatism/ corneal
opacification,anisometropia ,unilater aphakia Nystagmus,After refractive surgery,
after penetrating keratoplasty, cosmesis and therapeutic lenses .Any acute or
subacute inflammation of the anterior segment of the eye .Acute and chronic
ocular infections.Any eye disease affecting the cornea, conjunctiva, and lids (e.g.,
epithelial fragility, endothelial failure, dry eye, allergy,
pinguecula,pterygium),Corneal hypesthesia, Uncontrolled
glaucoma,Vitreocorneal touch in aphakia, Psychological intolerance to the
placement of a foreign body in the eye.All of these contraindications are relative.
If any contraindication is eliminated, the patient can be reevaluated, remembering
that a successful fitting is almost always based on a strong indication. 3 About 2%
of the world population uses contact lenses. The worldwide worth of lens market

3
was around 11.7 billion dollars by 2015.5Although lens designs and materials
have advanced, a considerable numbers of soft CL wearers complain of clinically
significant signs and symptoms, including the foreign body sensations, redness,
and CL-related dry eye. About 30% to 50% of CL wearers report the dry eye
symptoms, and dry eye is gradually becoming a public health problem. 4 Two third
of the population who wear lenses is female, and the average age of soft contact
lens wearers was 31 years.5 The comfort level of lenses depends upon its softness
and stiffness.RGP contact lenses reduce TBUT upto4 to 6 sec whereas soft
contact lenses decrease TBUT up to 4 to 10 sec.6 Moreover, discomfort or
irritation associated with dry eye may lead to intolerance of cls. Such symptoms
should be addressed in time to prevent its an occurrence. As generally agreed
upon, successful cls wear depends on the stable tear film.4The role of the tear film
in successful contact lens wear cannot be over-emphasised as its stability and flow
rate determine comfort and tolerance of lens wear. For this to be achieved, a well-
fitted lens should have the least effect on the cornea, the tear film and the blinking
process. The most contacted tissue in the anterior segment of the eye during
contact lens wear is the cornea. Measurements aimed at arriving at the contact
lens parameters are related in most cases to the cornea to make sure that its
activities are not affected. The pre-corneal tear film which supplies the oxygen
requirement for normal metabolism of the corneal epithelium should not be
destabilized by contact lens wear.The fit of the lens must be adequate enough to
allow for the elimination of metabolic wastes through the tear film by proper
circulation of tears between the lens and the cornea. When the integrity of the tear
film, whether stability or flow rate, is compromised, lens adhesion to the cornea
and rapid build-up of deposits on the lens surface are imminent. 7 The lacrimal
glands tear film and corneal surface play a major role to preserve the integrity of
the refractive surface of the eye, counterattack damage and defend the eye
contrary to varying biological circumstances. Tear film is protects the palpebral
conjunctivae, bulbar conjunctiva and cornea. Consequently, ocular discomfort is
due to tear deficiency or excessive tear evaporation.5Tear film is a complex and
exquisite fluid which is secreted by various glandular structures, it coats and

4
protects the ocular surface.6The tear film is based on three coatings; aninner most
mucin coat, a central aqueous coat and an external lipid coat which helps in
prevention of tear evaporation. In the eyelid, Meibomian glands produce a topical
layer of oils that lubricates and stabilizes the surface of eye so it could be
prevented from tear evaporation. The accessory tear glands and the glands of the
upper lid produced the middle layer which is the thickest and the biggest layer and
it carries diluted salt-water solution. The aqueous layer becomes stabilized
through the third mucin coat which gets lubricating secreation as of goblet cells
and through this stabilization, the aqueous layer helps to resist the bacterial
infection.These three layers help to keep conjunctival epithelium and cornea
moisturized. Impairment in any of these layers can cause tear hyper-osmolarity
through more tear evaporation or the less production of aqueous tear. Lipid layers
of tear films play a vital part in covering the eye from the outer environmental
pressure. In the lipid layer, there are Meibomian gland that cover the whole
cholesterolester and the lipid cholesterol. Malfunction in Meibomian gland of the
tear film lipid coat is the main reason for eye sickness.8 It was hypothesized that
CL wear leads to changes in the structure or the production of the meibomian
glands leading to alterations in lipid layer thickness, TF instability, an increased
tear osmolarity and dehydration of hydrogel lenses.9 Furthermore increased in
phospholipids level has been reported incontact lens user’s tear film. It causes
oxidation and degradation of phospholipids which leads to lysophospholipids and
diacylglycerides production. These are highly unsaturated and unstable. Hence
earlier disruption of lipid layer occurs, reducing of tear film stability.8 Thus tear
film stability measurement signifies its role as an imperative investigation
procedure especially in contact lens user.10
The tears are distributed by normal, non-voluntary action of eyelid and each blink
refreshes pre-corneal tear film. When blinking is held, evaporation of aqueous layer
of tear film started which causes thinning of tear film in a localized area.
Subsequently dry spots are formed in tear film when tears evaporate. Tear film
stability is usually measured by its lack of stability, by a test called Tear film break-
up time (TBUT). TBUT is the time taken in seconds for the tear film to break

5
following a blink cessation. Tear break up time TBUT of 15-45 sec is considered
normal while less than 10 sec is abnormal and less than 5 sec is suggestive of
symptoms of dry eye disease.6 When tear film becomes unstable due to less tear
production or poor quality, then it becomes a cause of dry eye disease caused more
evaporation in tears. Many risk factors contribute a lot to this disease such as clinical
illness, environmental, ocular and it could also be some personal factors. Patients
could note the symptoms and signs when tear film layers go through changes. The
symptoms which could be noted are irritation, dryness in the eyes, redness, burning,
soreness and sensation of grittiness. The people who use contact lenses experience
more symptoms than other people. Sometimes patients also experience blurriness,
stringy discharge and changes in vision. These symptoms go worse in low humidity
atmosphere, dry weather and high temperature. Contact lenses discomfort could be
caused by many reasons and whether or contact lenses themselves might be a reason.
Contact lens might be a reason due to its material, cleaning, design and maintenance.
An infection, expanded risk of ocular surface dryness, bacterial contagion, depletion
in wearing time, and reduction in functional visual acuity might be causes for dry eye
and alteration of the tear film which could be found in contact lens wearers.8 There
are many other factors that affect tear film stability including senile changes, ocular
conditions like blephritis, meibomian gland dysfunction or any primary ocular
surface disorder, hormonal changes, drugs like contraceptives, ant icholinergic,
antidepressants, antipsychotic, Vitamin A deficiency and environmental changes.As
generally agreed upon, successful cls wear de- pends on a stable tear film, including
the production and maintenance of the constituents in each of the layers. Several
studies have shown that cls produce a series of biochemical and biophysical changes
in the ocular surface, such as in the integrity of the tear film and ocular surface
microenvironment.
The physical adjustment of a contact lens over the ocular surface divides the tear
film into two parts, that is a pre-lens tear film and a post-lens tear film and it forms a
new interface within the ocular atmosphere. This division and new interface induce
changes in biophysical properties of tear film.6 Nature and quality of lens is
substantial and the wet ability of the lens is play an energetic part in the appearance

6
of the outer pre lens tear film’s lipid coat. Pre lens tear film’s aqueous layer starts to
decrease when the tear film separates. The contact lens surface does not contain as
much water as the corneal surface does because the lens surface does not have
enough hydrophilic nature. This is the main reason that why pre-lens tear film easily
breaks and becomes unbalanced in a very short time after blinking. When the tear
film breaks, it increases the friction between the surface of the eye and the eyelid
because the surface does not get enough lubricant from the tear film. The friction of
the corneal and the contact lens also increases if the tear film starts becoming thinner
due to lack of tear volume. While the friction increased between the ocular surface
and the contact lens, the feeling of discomfort, dryness and a foreign body begins to
start. The dry eyes due to the contact lenses are categorized as a second. Contact lens
wearers who are symptomatic have lower stability in the tear film and have lower
tear film break up rate which is primarily linked with the aqueous layer and tear film
breakup time. The main reason why people are intolerant to contact lenses is a low
volume of the tear.8 The contact lens use mainly alters the normal sequence of tear
film function and cause distractions in quantity and quality of the tear film, which
lead to contact lens intolerance.6 Epidemiologic literature has recognized prevalence
rates of dry eye from 33% and 7% in Japan and the US respectively. About 33.7% in
Taiwan and around 20.7 million people of the total population ofthe US have dry eye
syndrome. Likewise; menopausal women are the significant part of the population
affected by the dry eye problem.5 At the slit lamp, one can observe debris in the tear
film; mucous frag- ments; corneal and conjunctival epithelial changes; conjunctival
vaso- dilation; tear meniscus height; and lid, lash, and blink irregularities. These
evaluations are best performed with white, diffuse light. Fluorescein staining , Tear
Break Up Time, Rose Bengals, schirmer test and phenol red thread test etc.3
To increase tear film stability, polymers such as hyaluronic acid have been suggested
for use. These polymers allow the correction of the tear film volume and improve its
functional characteristics by increasing the tear film volume, ocular surface
wettability and fluid spreading. Recently, a new generation of multiple-action tear
substitutes, made of a combination of polymers with different characteristics, was
put on the market.11 They should be used frequently, at least four times a day, to

7
enable stabilisation of the ocular surface. Factors to consider when prescribing
artificial tears are the viscosity, the preservatives and the substitutes. Low viscosity
drops require more frequent administration, but they will not blur the vision, in
contrast to high viscosity drops, which have a prolonged effect but might cause
blurred vision. Therefore, viscous paraffin-based ointments might be better
administered only at night. Preservative-free drops are always better, as they do not
exacerbate the inflammation in DED, but they are more expensive and this cost
should be considered as the treatment is chronic.As for the substitutes, hypromellose
0.3 % or polyvinyl alcohol drops are two of the simple lubricant drops that are
popular for mild eye dryness. Carboxymethylcellulose 0.5 % in combination with the
osmoprotective compatible osmolyte erythritol and glycerine is a more effective
choice in providing cytoprotection and also osmoprotection simultaneously and thus
requires less frequent use. This is comparable to the sodium hyaluronate 0.18 %,
which is also cytoprotective and seems to have improved ocular surface retention to
inflamed eyes, due to a specific binding to the CD44, a transmembrane cell surface
adhesion molecule. Lid hygiene is also advised as initial management of dry eye
diseases, when posterior blepharitis is an underlying causative factor. Warm
compresses, lid massage and lid washing with a baby shampoo or soda solution will
help empty the meibomian glands and improve secretion. Cases of anterior
blepharitis, less common than posterior, are characterized by inflammation at the
base of the eyelashes.10 This study is conducted to evaluate the tear film break up
time (TBUT) and to find out correlation between tear film break up time (TBUT)
with contact lens wear.6
It is recently found that almost 50 % of Contact lens users have dry eye signs while
other reports showed that contact lens contributes more to symptoms of dry eye.
Recent study concluded that tear film stability depends on duration of contact lens
use. As wearing time increases, TBUT (tear film breakup time) decreases. It will
provide us a substantial approach for quantitative assessment of tear film stability. It
will allow us to conclude that if contact lens is affecting, or not, the tear film.

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 CHAPTER 2
LITERATURE REVIEW

Contact lens is Fine, Clear artificial optical device that attached on anterior
corneal surface of the user. It is used for several purposes but largely used for
correction of vision and for cosmetic reasons. They are of three types soft, rigid
and hard contact lenses.140 million contact lens users are present worldwide two
third of which are females mean age of contact lens users are 31 years. Wearing
schedule of contact lens are daily disposable, daily wear, extended wear, frequent
or planned replacement and conventional wear. Tear film has three layers secreted
by lacrimal glands it protect and cover the ocular surface, contact lens float on it.
According to many researcher tear film stability is effected in contact lens users
e.g. short tear film breakup time which cause dry eye symptoms and user feel
discomfort specially those who use contact lens frequently from years.dry eye is
caused by deficiency of tear or too much tear evaporation .besides
Design ,cleaning, material and maintenance of the contact lens duration of usage
might contribute to dry eye problem in contact lens users. When water from the
contact lens surface was evaporated it soak up water from tear film, measurement
of tear film break up time among contact lens users can lead to evaluate the cause
of dry eye symptoms. Ocular lubricant are suggested to use for treatment of dry
eye as they improve tear film stability by increase of tear film volume, spreading
fluid and increasing wettability e.g. polyvinyl alcohol 6

Guillon et al in 1997 conducted a study to characterize (structure, volume, and

stability) the preocular tear film of contact lens wearers and non-wearersand, to
test for any difference between contact lens users and non-users and between
symptomatic and asymptomatic individuals. The tear film structure and stability

9
were assessed using the biomicroscope observation system. The tear prism height,
which is indicative of the tear volume, was measured via slit lamp. The study was
carried out on 239 subjects (478 eyes). Out of these 184 was habitual daily soft
contact lens wearers who had not been wearing contact lenses for at least 24
hours, the other 55 were noncontact lens wearers. The results showed that the
stability of the tear film was correlated for two eyes of the same individual the
structure, volume, and stability of the preocular tear film were similar for both
groups no difference in tear film stability was found between asymptomatic and
symptomatic contact lens wearers, but a remarkable difference was found
between asymptomatic and symptomatic noncontact tact wearers; and the stability
of the tear film was affected by the nature of the lipid layer present at the surface
of the aqueous layer and the greatest stability was achieved when the lipid layer
was thick and homogeneous12

Toit et al did a research work in 2001. The aim of the study was to assess the tear
film, ocular surfaces, and symptoms of ocular discomfort in a presbyopia
population before and after contact lens wear.150 presbyopes (49% were previous
soft contact lens wearers) participated in a clinical trial in which they wore either
monovision or Bifocal contact lenses. This study showed that after 6 months of
contact lens wear, clinical signs had worsened by less than one-half of a grade,
and tear break up time (TBUT) worsened by 3 s. Only TBUT was lower for the
older individuals. Females had more sensitive eyes, more lissamine green
staining, and lower TBUT and phenol red thread measurements (all p<
0.04).Twenty-eight % experienced dryness before contact lens wear, but this
percentage increased to 68% when wearing contact lenses. These results provide a
representation of the ocular surface condition and symptoms of ocular discomfort
in the middle-aged population and similar in young population. Wearing contact
lenses seems to influence dry eye symptoms more than age or gender. So,
presbyopes should not be excluded from consideration for contact lens fitting.13

A research work was done by Çakmak et al in 2003 to examine the effects of soft
contact lenses on tear breakup time (TBUT), basal Schirmer test results, and the

10
conjunctival surface in patients using contact lenses. The study enrolled soft
contact lens wearers who were followed up in the Department of Ophthalmology
of Dicle University and 80 eyes of 40 subjects as a control group. After TBUT
and basal Schirmer test, conjunctival surface epithelial morphology was analyzed
using impression cytology. Results revealed that contact lens wearers were
divided into three groups according to the duration of contact lens wear. When
these groups were analyzed according to the Nelson grading method, 21% of
cases were grade 0; 32% were grade 1; and 28% were grade 3. They suggested
that TBUT and Schirmer test results be carefully monitored in contact lens
wearers. Impression cytology may be a safe, simple, and noninvasive method in
the diagnosis of ocular surface alternations in patients with contact lens
intolerance.14

In 2003Glasson et al studied about the contrasts in Clinical Parameters and Tear

Film of Tolerant and Intolerant Contact Lens Wearers. The Purpose of the study
was to decide if intolerance to contact lens wear is owing to clinical or protein
attributes of the tear film. In this research 38 subjects took part 20 were regular
contact lens wearers and 18 had stopped contact lens wear due to distress. With
no lens wear tear film baseline examination with the help of verity of clinical
measurement and examination of protein(lysozyme,lactoferrin and siga) were
performed. After 6 hours of lens usage, comfort was assessed, as well as changes
in tear film characteristics between groups of subjects. Discriminant analysis was
utilized to generate an estimate for determining the probability of intolerance to
lens use in half of the study population (n = 19).The remaining subjects were used
to test the formula for susceptibility and precision. These equations were
additionally tried on a different set of subjects signed up for a contact lens
wearing temporarily. The results calculated were that a more prominent number
of symptoms were accounted for by intolerant than by tolerant wearers (P <
0.05).Tolerance was related with clinical yet not protein attributes of the tear film.
Formulas had high sensitivity and specificity which went from 29% to 57%.Tear
stability measured non-invasive tear break up time and tear volume measured by
phenol red thread test and meniscus height those were essentially decreased in

11
Intolerant wearers (P < 0.05). Tolerance was not linked with protein attributes of
the tear film but with the tear film’s clinical attributes. Formulas was best ready
to anticipate contact lens intolerance non-invasive tear break up time, tear film
meniscus height and account of symptoms experienced The conclusion was that
the Contact Lens intolerance seems, by all accounts, to be best anticipated by a
blend of clinical factors including symptom detailing, tear film stability and tear
volume.15

In 2006, Rubido conducted a study. The aim of this study was to evaluate the
longitudinal changes in ocular physiology, tear film characteristics, and
symptomatology experienced by neophyte silicone hydrogel (SiH) contact lens
wearers in a daily-wear compared with a continuous-wear modality and with the
different commercially available lenses over an 18-month period.45 neophyte
subjects were participated in the study and randomly assigned to wear one of
these two SiH materials: lotrafilcon A or balafilcon A lenses on either a daily or
continuous-wear basis. Objective and subjective grading of ocular physiology
were carried out together with non-invasive tear breakup time(NITBUT) tear
meniscus height (TMH). Results showed that objective and subjective grading of
ocular physiology revealed a small increase in bulbar, limbal and palpebral
hyperemia as well as corneal staining over time with both lens materials and
regimes of wear (p< 0.05). No significant changes in NITBUT or TMH were seen
(p> 0.05). This study concluded that daily and continuous wear of SiH contact
lenses induced small but statistically significant changes in ocular physiology and
symptomatology. Clinical measures of tear film characteristics were not affected
by lens wear. Both materials and regimes of contact lens wear showed similar
clinical performance. Long-term silicon hydrogel contact lens wear is shown to be
a successful option for patients.16

In 2008 Guillon et all studied about impact of contact lens usage on evaporation
of tear film. Thepurose of the study was to evaluate evaporation of tear film in
contact lens users and non users. They test following hypothesis i. Evaporation of

12
tear film was higher amongst contact lens useres when they worn contact lens.
(ii) In the absence of contact lenses evaporation

of tear film of contact lens users was higher than noncontact lens users. At 30 and
40 percent mean humidity, the rate of evaporation of the tear film was measured.
They divided 379 subjects into three groups one was non-contact lens users(n =
139) second was contact lens users(n = 111) and third was wearer of contact
lenses who did not wear them on the day of the visit.( n = 129). At both
humidities, identical rate of evaporation was found in the right and left eyes. The
contact lens user’s evaporation rate was substantially higher than the wearer of
contact lenses who did not wear them on the day of the visit and the non-contact
lens users. For the contact lens users, the rate of evaporation remarkably
decreased than for non contact lens users between normal (40%) climatic
conditions the dry (30%) ones. Furthermore, even after 1 day without contact
lenses, the contact lens users evaporation rate was considerably higher than the no
users. The study found that when a contact lens is worn, the rate of evaporation is
faster even after 24 hours without using contact lens, this impact could be linked
to tissue and/or tear film alterations. During conditions of normal humidity (40%)
contact lens user experienced more evaporation than non-contact lens users did in
low humidity (30 percent ).it could be the explanation of high rate of dry eye
complaint in contact lens users and non user.17
Wang J et al conducted a study in 2008, research was done utilising real-time
optical coherence tomography (OCT) to locate upper and lower tear menisci on
contact lenses. When 20 adapted contact lens wearers wore silicon balafilcon A
on one eye and galyfilcon A on the other, both eyes were photographed. On two
consecutive days, the height, radius, and area of upper and lower tear menisci
were measured before, immediately after, and 20 minutes after lens use. The
lenses were transferred between eyes on the third visit, and an investigational
lubricant was applied after 4 hours of lens usage. OCT pictures were taken as
previously, but also at 1 and 4 hours after the lens was inserted. Imaging was
performed immediately after lubricant instillation and again 20 minutes
afterwards. The menisci surrounding both eyelids were substantially larger soon

13
after lens installation than before (P 0.005). All variables had recovered to
baseline levels within 20 minutes following lens installation and had remained
that way for at least 4 hours. Meniscus variables rose (P 0.001) immediately after
the lubricant was injected at 4 hours, but they returned to baseline within 20
minutes. When contact lenses were inserted and lubricants were administered, tear
menisci increased.18
A research study was conducted by Qi Chen et al in 2009, to assess tear meniscus
volumes during short-term lens usage by soft contact lens (SCL) wearers
experiencing dryness complaints. Three groups of 20 people were chosen. SCL
wearers with self-reported dryness made comprised Group 1. Asymptomatic
wearers made up Group 2. Asymptomatic non-lens wearers made up Group 3.
Each eye was put with contact lenses, and the upper and lower tear menisci were
scanned using optical coherence tomography before, shortly after, and 30 minutes
afterwards. The tear meniscus area was computed using custom software, and the
volumes were determined based on the length of eyelid. On two separate days, the
repeatability of the lenses was examined 30 minutes after they were worn. Dry
eye symptomatic wearers had lower tear volumes at baseline and throughout lens
usage than healthy wearers, which might have exacerbated to the dryness.19
In 2009 a study was conducted by Qihua L et al. In this study spectral optical
coherence tomography (SOCT) was used to assess the changes in the tear
meniscus in eyes equipped with soft contact lenses (SCL). This study included 33
normal people and 33 contact lens wearers who had been using daily-wear
frequent-replacement SCL with a water content of 55 percent for more than 6
years on average. SOCT was used to investigate the meniscus at the left eye's
central lower lid. The examination was done twice for contact lens wearers: once
with and once without the lenses. The assessment was only done once for those
who did not use lenses. The hyperreflective curved layer (P1) and the
hyporeflective triangular region were separated in the picture of the lower tear
meniscus (P2). P1 and P2's heights (H-P1 and H-P2), as well as the thickness and
area of both portions (T-[P1+P2] and A-[P1+P2]), were measured. Before
removing the lenses, the mean values of H-P1, H-P2, T-[P1+P2], and A-[P1+P2]

14
were 164.18 +/- 41.77 microm, 148.6 +/- 42.84 microm, 134.72 +/- 38.39
microm, and 9914 +/- 469 microm, respectively. When CL was removed from the
measurements, there were no significant variations in the results. Long-term SCL
use was found to cause reduced tear volume, mostly due to a decrease in the
aqueous component.20

Szczesna D et al in 2011 did a research work to measure tear film surface quality
in healthy and dry eye subjects using three noninvasive techniques of tear film
quality assessment and to establish the ability of these noninvasive techniques to
predict dry eye. Thirty-four individuals participated in the study. Results were
found to investigate the capability of each method to discriminate dry eye subjects
from normal subjects, the receiver operating curve was calculated and then the
area under the curve was extracted. The best result was obtained for the
LSI(lateral shearing interferometry) technique [AUC= 0.80 in Suppressed
blinking condition (SBC) and AUC= 0.73 in natural blinking condition (NBC)],
which was followed by HSV(high-speed video keratoscopy)[AUC= 0.72 in SBC
and AUC= 0.71 in NBC]and the best result for DWS(wave front sensing) was an
AUC of 0.64 obtained for changes in vertical coma in SBC, whereas for NBC, the
results were poorer. In conclusion, this study stated that noninvasive techniques of
tear film surface assessment can be used for predicting dry eye, and such an
analysis can be achieved in NBC as well as SBC. In this study, LSI revealed the
best detection performance, closely followed by the dynamic-area HSV. The
DWS technique was less powerful, particularly in NBC.21
A Prospective case-control research was done in 2011 by Kojima et alto evaluate
the effect of contact lens (CL) wear and visual display terminal (VDT) work. The
study included 69 contact lens wearers and 102 non-contact lens wearers. The
participants were separated into four subgroups based on total VDT work time in
a single day (VDT work time in a single day 4 hours or 4 hours) and CL wear.
Ocular surface vital staining scores, Schirmer test findings, tear film break-up
time, tear meniscus height measurement, and dry eye symptom questionnaire
score were the main outcome measures. CL users and long-term VDT employees
had substantially lower tear meniscus height values than non-CL users and short-

15
term VDT employees (P.001). CL wearers and long-term VDT employees had
considerably higher mean visual symptom scores than the other groups (P.001).
Office employees who wore CLs and worked on VDT for more than 4 hours had
a reduced tear meniscus volume, as well as severe dry eye and visual complaints
produced by the environment.22
A study was undertaken in 2011 by Tao A et alto see how overnight contact lens
usage affected the tear meniscus, tear film stability, and subjective comfort. Sixty
healthy people were put into three groups. Twenty non-CL wearers made up the
control group. Group 1 and group 2 were made up of twenty inexperienced CL
users and twenty experienced CL wearers. A hydrogel and a silicone hydrogel CL
were randomly allocated to each eye of each individual in groups 1 and 2. The
upper and lower tear menisci were measured using optical coherence tomography.
Tearscope measurement of non-invasive tear break-up time (NITBUT). Dry eye
symptoms were examined using a previously utilized questionnaire. Subjects were
assessed for 11 hours, including before and after sleeping. Tear meniscus volume
rose immediately after waking in the control group and recovered 1 hour later (p
0.05). In contrary, the amount of the tear meniscus rose when the eyes were
opened and then returned to normal after 10 minutes (p 0.05). At eye opening, CL
wearers had lower tear meniscus volumes than controls. After CL implantation,
NITBUT and comfort ratings both dropped (p = 0.00). NITBUT was higher than
pre-sleep levels until 10 minutes after eye opening. Until 5 minutes later, the
comfort score was lower than the pre-sleep levels. Both inexperienced and
experienced CL users exhibited dynamic changes in the tear menisci, NITBUT,
and comfort level during and after overnight wear. Lower eye comfort for longer
CL users may be due to decreased tear meniscus volumes and tear film stability.
Tearing on eye opening may aid in ocular comfort and tear refreshment, allowing
the tear system and CL to be reconditioned.23
An experiment was done by Chen Q et al in 2011, to determine the link between
tear meniscus volumes and ocular pain during daily soft contact lens usage in
symptomatic and asymptomatic wearers. There were three groups of subjects
(each with n = 20). Symptomatic lens wearers are in group 1, asymptomatic lens

16
wearers are in group 2, and asymptomatic non-lens wearers are in group 3.
Optical coherence tomography was used to examine both eyes after wearing
lenses for 2, 4, 6, 8, and 10 hours (OCT). After that, a rewetting drop was instilled
into a randomly selected eye of each participant, and they were re-imaged right
after, as well as 5, 10, 20, and 30 minutes later. At each time point, the upper and
lower meniscus volumes in group 1 were the lowest of the three groups (P 0.05).
During the 10-hour testing period, meniscus volumes dropped gradually in each
group (P 0.05). The tear meniscus volumes throughout the 10 hours of lens use
were linearly linked with the comfort assessments in each group (r = 0.21-0.47,
both P 0.05). Rewetting increased tear volume, but only for 10 to 20 minutes.
After instillation, ocular comfort rose in groups 1 and 2, although only for 10 and
20 minutes, respectively. Group 3's ocular comfort did not increase. Tear volume
dropped progressively while using contact lenses, contributing to ocular comfort
in both symptomatic and asymptomatic wearers. The effectiveness of rewetting
was just transient.24

In 2014 pili et al studied about the problem of dry eye in soft contact lens
users.The purpose of the study was to investigate the link between the problems
that are self reported by rigid gas permeable and soft contact lens users regarding
dry eye disease. Researcher select 84 eyes of patients who were wearing rigid gas
permeable and soft contact lens all of them aging between 15 and 71 wearing
lenses almost daily for above an year. Data collection was done by assessment of
symptoms with respect to ocular surface disease index along with clinical
assessment of subjects included measurement tear film breakup time and
fluorescein staining of cornea according to staining grid of the National Eye
Institute. Researcher found that among rigid gas permeable contact lens users the
ratio of female patients was more than that of male i.e. 76.19% and 23.71%
respectively. The average duration of wearing lens was 7.71±2 72 hours. Among
rigid gas permeable contact lens users no patients had a National Eye Institute
corneal staining grid score more than 2. The duration of daily lens wear and tear
film break up time were found to have a weak negative connection and coefficient
value ofocular surface disease index( r= -0.1467).Finally researchers concluded

17
that It is important to diagnose the problem of dry eye accurately and as soon as
possible for successful and long term use of soft contact lens and rigid gas
permeable contact lens.25

In 2014 Lan et al did a research work to compare the effects of different volumes
of fluorescein on tear breakup time (FTBUT) and to investigate the extent where
the tear breakup time determined by an automatic noninvasive instrument
(NITBUT) differs from FTBUT. 24 healthy volunteers were recruited to the
study. Fluorescent tear breakup time was measured with different volumes of
fluorescein solution delivered by either glass rod or fluorescein strip.
Mearurements of Noninvasive tear breakup time was taken by noninvasive
instrument (Oculus Keratograph 5M, Germany; K5). Results revealed that
Increasing the volume of fluorescein delivered from 1 to 7 μl lengthened FTBUT
by a mean ratio of 1.26-fold (p = 0.019) for the glass rod technique. No notable
difference was detected in the FTBUT measured by the fluorescein strip
technique when the delivered volume was increased from 4.5 to 7 μl. The
variability level of successive recordings was stable across the tested volumes for
both techniques. Noninvasive tear breakup time was determined by K5 was
significantly longer than FTBUTs (mean difference: 3.90 seconds, p = 0.003 and
4.12 seconds, p = 0.002, respectively). Although no considerable difference was
detected in the average SD for successive recordings among K5 and the other two
invasive techniques (p = 0.325), the variability of NITBUT was found
significantly dependent on the observed measurements of TBUT (r = 0.532, p =
0.007). This study concluded that the Oculus Keratograph 5M usually produced
substantially longer TBUT compared with invasive techniques tested. The
variability level of readings by this novel method increased with the values of
NITBUT. However, these findings need to be confirmed in a larger study.26

In previous studies Fukui et al in 2016 conducted a case control research study

on Fluorophotometric Analysis of the Ocular Surface Glycocalyx in Soft
Contact Lens Wearers. The purpose of this study was to examine glycocalyx of
ocular surface among soft contact lens users by fluorescein-labeled wheat germ

18
agglutinin as an indicator to illustrate ocular surface glycoconjugates of subjects
in vivo. Unsteady tear film is indicated by decreased tear film breakup time
which is associated with dry eye and symptoms of discomfort among contact
lens users. Glycocalyx believed to be essential in keeping the ocular surface
wettable and lubricated. The study included 20 regular soft contact lens wearers
and 20 healthy volunteers those had no history of using contact
lens(controls).Resercher used 5% fluorescein-labeled wheat germ agglutinin in
eyes of subjects and fluorophotometry was used to assess fluorescence
intensities in the central corneas of of research participants. The link between
corneal fluorescein-labeled wheat germ agglutinin intensity and clinical factors
related with contact lens wear was investigated. Among soft contact lens users
fluorescence intensity of fluorescein-labeled wheat germ agglutinin was 418.5 ± 
103.3,on the other hand among control group its value was considerably
lower(825.0 ± 179.8; p < 0.0001) The intensity of fluorescein-labeled wheat
germ agglutinin of fluorescence was not correspond with Schirmer's test values
or age, but there was a statistically significant association between fluorescence
intensity of fluorescein-labeled wheat germ agglutinin and tear film BUT was
noticed (r = 0.77, p 0.0001). From this study they concluded that depletion of
ocular surface glycocalyx and/or compositional changes may be one of the
causative component of soft contact lens-induced eye dryness.27

Waleed et al studied effect of time period of contact lens wear on the meibomian
gland’s function and morphological structure in year 2016. The solid purpose of
the study was to evaluate the impacts of time period of contact lens wear on the
tear film meibomian gland and eyelids. Researchers conducted a cross-sectional
investigation on contact lens wearers and non contact lens wearers matured
somewhere in the range of 18 and 35 years. Their sample size was 100 and they
divided them into three groups of contact lens wearers on the basis of time
duration of contact lens usage, one of them was the group of people who are
contact lens users and have different time duration of wearing contact lens(eg.
long, moderate and short duration).Second was the group of people who stopped
wearing contact lens almost 6 months before this study and the third one was the

19
control group consisting of healthy non contact lens users. They collected data by
assessment of subject’s symptom , evaluation of tear lipid layer, measurement
non-invasive tear film break-up time, examine area of tear meniscus, calculation
of tear evaporation and osmolarity, recorded the results of Phenol red thread test,
examination of expressibility of meibomian gland, assessments of eyelid and
ocular surface by using lissamine green lid wiper and Marx line assessment and
meibography. They had continuous data with categorical and ordinal variables.
They use SPSS software for the analysis of their
data.Atotal of 100 subjects (49 men and 51 women; mean age SD: 25.4 4.1) were 
enrolled, with each group consisting of 20 sex /age subjects matched. Between
research groups remarkable difference was found in results of the research.  For
expressibility of meibomian gland (p < 0.001),tear meniscus area
(p = 0.029),palpebral redness (p = 0.003), Phenol red thread (p = 0.005),count of
plugged orifices (p = 0.001), non-invasive tear film break-up time (p < 0.001),
number of expressed orifices (p < 0.001), roughness (p = 0.002), Marx line score
(p < 0.001), meibomian gland dropout (p = 0.001), among subjects from all other
groups in non contact lens users these factors were different. Time period of
contact lens wear found to be insignificant factor, except for score of marx line
which was different in previous contact lens wearers compared to t with contact
lens wearer(p = 0.03) with longer experience.They concluded that contact lens
caused alteration to function of meibomian gland and its morphology.These
progressions although began during the initial 2 years of wear, continued contact
lens exposure beyond this time does not appear to be linked to additional
alterations. Suspension of wear for at as long as a half year did not result to cure.28

In 2016 Reddy et al studied in malaysia on university student about dry eye

symptoms among contact lens wearers and non-contact lens wearers. Purpose of
this research was to find out how common dry eye problems are present among
university students who wear contact lenses and those who don't .They want to
figure out any relationship between dry eye symptoms and gender, In addition
they want to evaluate the presence of any link of dry eye symptoms and computer
usage in contact lens users. Sample size was 627 from them Females were 406

20
(64.8%) more than males 221 they all were pharmacy and medical students of 18
to 28 years old. For contact lens wearers they employed the contact lens dry eye
questionnaire (CLDEQ) and the dry eye questionnaire (DEQ) for non-contact lens
users. Both forms included questions regarding demographic data, common
symptoms and mode of relief. The intensity and recurrence of the symptoms were
used to assess their nature. SPSS software was used to analyze the questionnaire
completed by subjects. The results show that every one of the symptoms of dry
eye were essentially more predominant in contact lens wearers when contrasted
with non-contact lens wearers. The most widely recognized side effect of dry eyes
experienced in contact lens wearers was dryness of eyes (73.5%), while tired eyes
(77%) was the most well-known side effect in non-contact lens wearers. Results
additionally showed a rising pattern in severity and recurrence of symptoms as the
day pass over, with the most peak intensity toward the contact lens wearing time
ending. Dry eyes symptom was noted altogether more frequently in understudies
involving use of laptop /computer screen for over 2 hours per day. Researcher
finally concluded that as compare to non contact lens users ,contact lens user
experienced Symptoms of dry eye and as the day progressed, the severity and
rate of occurrence of symptoms increased, peaking towards the the ending time
period of contact lens wearing. More than 33% of contact lens users get
alleviation of the side effects in the eyes by contact lens removal.29

In previous studies Guillon et al in 2016 studied about association of tear film

dynamics and complain of discomfort caused by contact lens. Furthermore, there
is a lack of information about the complete tear film dynamics throughout the
inter-blink phase in contact lens users. The goal of this study was to find aspects
of the pre-lens tear film dynamics that could be linked to contact lens discomfort
complaints. Researchers select 202 soft contact lens users (silicone hydrogel and
hydrogel) subjects who came in for pre-screening visits at the OTG-i research
clinic. All subjects filled questioner of Ocular Surface Disease Index. Researchers
recorded data of tear film of each patient at visit by tear-scope. Then analyze it by
post hoc to quantify tear film. The least symptomatic user’s tear film dynamics
were compared to the most symptomatic user’s tear film dynamics. The

21
hypothesis was that asymptomatic contact lens user's tear film dynamics were
better than symptomatic contact lens user's tear film kinetics. Silicone hydrogel
lenses made up 48.2 percent of the lenses, while hydrogel lenses made up 51.8
percent of the three categorized according to type of contact lens used that are
46.5% daily Disposable, 13.6% 15 days Replacement and 39.6%1-Month
Replacement. Symptomatic contact lens users had reduced tear film surface
coverage during the inter blink period (p <0.001 , 95.1% vs. 98.5%), more surface
exposure during the blink(p = 0.001, 9.4% vs. 3.9%;) and a faster break-up time(p
= 0.0034.7 s vs. 6.0 s). The tear film dynamics of asymptomatic and symptomatic
contact lens wearers differed. Results of their study helped to confirm the
hypothesis. In the general population of contact lens users symptomatic subjects
have lower tear film dynamics than asymptomatic subjects.30

A cross sectional study was conducted by Ammer et al in 2017. The purpose was
to determine the effect of contact lens wear on tear film break up time (TBUT)
and to find out correlation between tear film break up time (TBUT) with type of
contact lens wear, daily wearing time of contact lens, years of contact lens use and
power of contact lens. TBUT was determined by using fluorescein strips and slit
lamp. A sample of 100 (67 females and 33 males) contact lens users enrolled for
the study. Mean age of sample was 30.10±7.86 years. Mean daily wearing time of
contact lens was 9.82±2.19 hours/day and mean of years of contact lens use was
8.35±5.81 years. 67% of 100 contact lens wearers had abnormal (less than 10
sec.) tear film break up time (TBUT). A significant negative correlation of TBUT
was found with daily wearing time of contact lenses (r=-. 251), years of contact
lens use (r=-. 542) and contact lens for myopic correction (r=-. 330). No
significant association of Tear Film Break-up Time was found with type of
contact lens and contact lens used for correction of hyperopia. This study
concluded that TBUT decreases with increase in daily wearing time, years of
contact lens use and refractive contact lens treated high myopia, while type of
contact lens and contact lens for correction of hyperopia did not notably affect the
TBUT.6

22
Uchino et al conducted a study in 2018, aimed International Journal of
Ophthalmology 11 (10), 1691, 2018 to investigate the association between tear
film break up time (TBUT) and blinking interval in visual display terminal (VDT)
users. 930 individuals of VDT users underwent dry eye testing, and functional
visual acuity (FVA) test. They found that among 930 workers, 858 subjects
(92.3%) participated in this study. Almost 80 percent of the individuals were
categorized into the unstable tear group. Unstable tear group has significantly
lower Schirmer values and TBUT (17.5±11.6 vs 21.1±11.5 mm, 3.7±2.6 vs
5.7±2.7 s, both P<0.001). Contact lens use was protective factor for being in the
unstable tear group (OR= 0.37; 95% CI= 0.26-0.53). They concluded that the
subjects with shorter TBUT than blinking interval are prevalent among VDT
users. Subjects over the age of 40 shows a great risk for unstable tear film.31

In 2018 Mousavi et al did a research work to evaluate the clinical value of non-
invasive keratograph tear film breakup time (NIKBUT) in the assessment of pre-
corneal and pre-lens tear film quality for prescribing contact lenses (CLs). Forty-
six individuals aged 25.5 ± 4.3 (mean ± standard deviation) years were recruited
in this study. Visual acuity (VA), anterior eye health checks and NIKBUT were
examined. Thirty-four individuals were fitted with SiHy (Silicon Hydrogel) and
twelve with Hy CL. No statistically significant differences were found for both
NIKBUT parameters between right and left eye at baseline (p = 0.38 and p = 0.50,
respectively) and post 4 hr of CL wear (p = 0.61 and p = 0.06). In 39.1% and
34.8% of cases (18 and 16 out of 46), there was a match between prescription
decision and the first and the mean NIKBUT results,respectively.Although there
is no evidence whether tear film surface quality measurement hasthe most striking
diagnostic values compared to other traditional clinical measures used in practice,
NIKBUT measurements have provided additional information that could be of
interest during CL fit.32

An observational study was conducted by siddireddyet al in April 2018 their topic

of study was The eyelids and tear film in contact lens discomfort. A sample of
thirty daily wear soft contact lens wearers (6 male; 24 female) with median age

23
of 23 years (range 18–41) were taken. A cross sectional study was performed on
them. During a single visit, Eyelid signs and tear film characteristics were
evaluated. And subjects filled the contact lens and dry eye questionnaire.
Researcher classified subjects into two groups, symptomatic and a symptomatic
on the base of responses of questionnaire. They found that thickness of tear lipid
layer(45 ± 17 nm), breakup time of tear film by fluorescein(8 ± 2 seconds),
evaporation rate of tears with contact lens is(112 ± 54 g/m2/h) and with out contact
lens is(88 ± 45 g/m2/h) more over foam atorifices of the meibomian gland
graded(3 ± 1) its secretions (2 ± 1) and expressibility (2 ± 1) they are remarkably
related to indication of unease in symptomatic contact lens user only(r2 > 0.45; p
value < 0.05).height of tearmeniscus , epitheliopathy of upper eye lid and acini
reflectivity of meibomian gland shows marked association with comfort count in
both categories of contact les users (symptomatic and asymptomatic)(p < 0.05).in
symptomatic lens users Demodex mites on upper eye lid is found (2 ± 1) on
contrary asymptomatic contact lens user (0 ± 0; p value = 0.042).on the bases of
their results they concluded that changes to tear film secretions that influence
dynamics of tear evaporation and Morphological asymmetry of meibomian glands
are source of symptomatic contact lens users because the show correlation with
indications of discomfort symptomatic contact lens users.33

In 2018 Itokawa et al studied about Relationship Between Ocular Surface

Temperature and Tear Film Stability in Soft Contact Lens Wearers. The goal of
this study was to see if there was a link between stability of tear film and changes
in temperature of ocular surface when wearing soft contact lenses. For this
purpose researcher used 4 different types of daily disposable soft contact lenses
on 20 eyes of normal soft contact lens users(20 men; 24.4 ± 4.1 years). The types
were three hydrogel lenses (polymacon,etafilcon A and etafilcon A with
polyvinylpyrrolidone) and one silicone hydrogel lens (delefilcon A).in clinical
evaluations they estimated without blinking temperature of Ocular surface after
each second for 10 seconds and the results from 0 to 10 seconds were called as
ΔOST. They measured  tear  film break-up time noninvasively and
Tear film interferometry was used to evaluate tear interference patterns on contact

24
lenses to assess tear film stability. They found that with contact lens (r =
0.642, P < 0.01) and with out (r = 0.411, P < 0.01) Ocular Surface Temperature
remarably linked with non invasivetear  film break-up time . Over soft contact
lenses (r = −0.636, P <0.01)grade of tear interference patterns on the contact
lenses was remarably linked with Ocular Surface Temperature. Silicone hydrogel
delefilcon A was much lower in ocular surface temperature than that of hydrogel
etafilcon A and polymaconlenses(P < 0.05 and P < 0.01, respectively). Non
invasive tear  film break-up time  was considerably lower in delefilcon A and
etafilcon A with polyvinylpyrrolidone lenses than in etafilcon A(P < 0.05 for both
comparisons. Tear The delefilcon A lens's lenses. Interference patterns on the
contact lenses grade was much lower than that of the etafilcon A and
polymacon.so they concluded that alteration in ocular surface temperature is
linked with stability of tear film and evaluation of ocular surface temperature
could be utilize for the assessment stability of tear film in soft contact lens users.34

In 2019 Pucker et al studied about Assessment of Systane Complete for the

Treatment of Contact Lens Discomfort. The main Purpose of this study was to
know if in symptomatic soft contact lens wearers a new artificial tear, which is
approved for both aqueous deficient dry and evaporative eyes, may safely relieve
contact lens discomfort. Adults with symptomatic Contact Lens Dry Eye
Questionanire-8 (CLDEQ-8 scores ≥ 12) were selected for two-week,
randomized, investigator-masked, clinical research. Sample size was 46 they are
divided in to two groups. 22 people received artificial tears and 24 received no
therapy. At beginning and two weeks, symptoms (CLDEQ-8, Standardized
Patient Evaluation of Eye Dryness (SPEED), self-reported) were assessed. They
measure their visual acuity, meibum expression quality; tear film breakup
time, Schirmer’s test I and corneal staining. Researchers found that the subjects
belonged to group used artificial tears had fundamentally better CLDEQ-8 scores
(12.86 ± 6.40 versus 17.92 ± 5.30; p = 0.006) yet not SPEED scores (7.55 ± 4.31
versus 9.29 ± 4.14; p = 0.17) at about fourteen days contrasted with the no
treatment group. No remarkable variations between both groups were noted for
any clinical signs at about fourteen days (all p > 0.29). No subject in either group

25
revealed any unfavorable occasions during the review. They concluded that in
symptomatic contact lens user Systane Complete was found to be reliable and
help to increasing contact lens comfort. Since the tested clinical symptoms
remained unchanged, more research is needed to better understand the
mechanism(s) that contribute to enhanced comfort.35

Rushda et al in 2020from College of Ophthalmology and Allied Vision Sciences,

King Edward Medical University, Mayo Hospital, Lahore studied the effect of
soft contact lens wearer on tear film breakup time. Researcher conducted a
descriptive observational study in which they collect the data from 30 female
contact lens users with mean age of 24.5 ± 5 years ,40% are cosmetic while 60%
were refractive contact lens users. Subjects were using contact lens for more than
3 months and had no ocular pathology associated with dry eye. Researcher use
Fluorescein sodium dye and examine tear film breakup time with the help of slit
lamp. They found that from 30 subjects only 6.67% had marginally decreased tear
film BUT and no one has dry eye. 4 patients had tear film discomfort with
contact lenses.Their subject had not abnormal tear film breakup time who were
using disposable and daily wear lenses. 15 patients were using extended were
contact lenses from which two had marginal tear film breakup time.the patient
who are contact lens user from 3-6 months their mean value of tear film breakup
time is 33sec but its 10 sec for those who were using contact lens from last 9-12
months. When tear film break-up time was compared among different types of
contact lens wearers, it showed that 33.33% of extended lens wearers had reduced
tear film break up time (range 6 – 15 seconds) as compared to disposable and
daily wearers who had tear film break up time of 35 seconds.5

In 2020 Tianpuet al studied about assessment of tear film and the morphological
changes of meibomian glands in youthful Asian soft contact lens wearers and
non-wearers. The point of this study was to investigate among contact lens users
and non-users the variations in aspect of tear film and meibomian glands.
Researcher conducted cross-sectional observational prospective stud by utilizing
148 subjects (63 non-wearers, and 85 soft cl wearers who had been wearing cls

26
for over 1 year) enrolled from a facility in Tianjin, China. All subjects previously
answered an ocular surface disease index form and afterward went through a
standardized dry eye assessment, which included non-invasive tear breakup time,
and, corneal staining with fluorescein and measuring tear meniscus height . The
meibomian glands were assessed by means of images, they count distorted
meibomian gland and recorded number of meibomian gland dropout. Reacher
found thatthe group of contact les user had higher corneal fluorescein staining
scores(r = 0.442, P < 0.001). And Ocular Surface Disease Index(r = 0.298, P =
0.006), lower non-invasive tear breakup time and tear meniscus height values, a
bigger malformed meibomian gland count, and a greater meibomian gland loss(all
P < 0.05).Than the control group (non-wearers)they found association between
time span of contact lens usage and loss of meibomian gland (r = 0.440, P
<0.001)they concluded that contact lens user expressed greater loss of meibomian
gland and decreased tear meniscus height and non-invasive tear breakup time they
play significant role in producing contact lens related dry eye intense complaints
this loss is also effect normal state of the tear film among contact lens users.4

A cross sectional study in 2020 was conducted by Kaido et al and their topic was
“Tear Film Dynamics of Soft Contact Lens-Induced Dry Eye”. Purpose of this
study was to evaluate tear film dynamics among subjects in which usage of soft
contact lens has induced dry eye. Their sample size was 17 and they use video
interferometry to evaluate dynamics of tear film with and without wearing contact
lens. Subjects were 11 men and 6 women with mean age: 36.8 ± 8.3 years.
Subjects were divided into two groups based on presence of symptoms of the dry
eye. Images of Interference focused on tear film spread and between both groups
they compared fringe of interference. Researcher found 7 asymptomatic and 10
symptomatic eyes among subjects Eight subjects who has symptomatic eyes show
multicolor fringe of interference which indicate poor tear film spread. Eight and
ten subjects show good tear film spread when they remove soft contact lensese.g
interference fringe is grayish and monochromatic. On the other hand, in
asymptomatic subjects, 6 eyes revealed good tear spread had grayish
monochromatic interference fringe with soft contact lenses and after removing

27
those soft contact lenses. Researcher concluded that by observing tear film
dynamics in soft contact lens wearers help to know symptoms related dry eye.
Dry eye that included by soft contact lenses has correlation with dynamics of tear
film only during the time subjects were wearing soft contact lens.36

In 2020 a prospective non-randomized simultaneous comparative cross-over study

was conducted by Montani et al to evaluate changes induced over time by three
daily disposable (DD) contact lenses on tear meniscus height (TMH), pre-lens
non-invasive break-up time (pre-lens NIBUT), tear film osmolarity (TO) and
objective quality of vision (OQV). 46 subjects were participated. Results showed
that TMH was same at 20 minutes wear of all lenses but was significantly reduced
after 8 or more hours wear (on day 7) of delefilcon A and stenfilcon A,
respectively. Pre-lens NIBUT was significantly reduced with all these lenses,
while no significant change in tear film osmolarity (TO) was observed with any
lens. This study concluded that any contact lens on the eye challenges the tear
film, nesofilcon A contact lenses, have their high water content, compared to
stenfilcon A and delefilcon A contact lenses, given a lower overall effect. We
concluded that superior tear film behavior while wearing nesofilcon lenses may
translate to improved subjective comfort but this remains to be evaluated.37

An observational study was conducted by Sohail et al in 2021. The purpose of this

study was to determine the tear film breakup time (TBUT) among contact lens
users. A sample of 342 contact lens users (age group 16-50) were enrolled in
which 236 (69%) were female contact lens user and 106 (31%) were male contact
lens users, 55% were myopic soft spherical contact lens wearer, 2.0% were soft
spherical contact lens user for hyperopia , 21.9% were plano cosmetic lens users
and 5.8% RGP contact lens users. Tear film breakup time (TBUT) was tested by
using fluorescein sodium dye and alcaine drop and this test was examined under
the cobalt filter on slit lamp. After examining the patients on slit lamp, a self-
designed Performa was filled. The daily wear time range from 6 hours to >12
hours and 62.6% subjects wear 9 to 12 hours per day. Overall TBUT reduced, tear
film breakup time ranges from less than 5 second to greater than 10 second in

28
contact lens user. The results showed that 93.6% had abnormal tear film breakup
time and 6.4% had normal tear film breakup time. This study concluded that tear
film stability depends on duration of contact lens use, as the wearing time
increased tear film breakup time TBUT was decreased.38

A retrospective observational study was conducted by Fujimoto et al in 2021. Soft

contact lenses (SCLs) are effective for refractive error correction, but prolonged
use triggers discomfort and discontinuation. This study aimed to investigates
whether water gradient technology of delefilcon A-based SCLs improve tear film
dynamics. 50 asymptomatic delefilcon A or narafilcon A users were enrolled.
Results of this study showed that TALB (thin aqueous layer break) was
significantly lower in the delefilcon A group compared to the narafilcon A group
(33.3% vs. 85.5% at visit 1; P< 0.0001 and 31.7% vs. 80.4% at visit 2; P<
0.0001). The NIBUT (noninvasive tear film breakup time) was also significantly
higher in the former (4.2±2.1 seconds vs. 2.9±1.5 at visit 1; P< 0.01 and 4.1±2.3
seconds vs. 2.7±1.6 seconds at visit 2; P< 0.01) across both visits. The TMH (tear
meniscus height) was significantly reduced in the former in both v1 and v2. The
total ocular Higher order aberration were significantly lower in the former at v1
(P< 0.001) and v2 (P< 0.05) compared to the bare eye, Conclusion of this research
work was that the water gradient technology of delefilcon A reduces TALB and
increases NIBUT.39

A randomized, crossover study was performed by Marqués et al in 2022. It was

done to compare the short-term effect of two contact lenses on pre-lens tear film
stability and comfort: dual-focus contact lens (MiSight) and a mono focal contact
lens (Proclear 1-day). Twenty-eight healthy, myopic volunteers aged between 18
and 32 years were participated. Tear Film Surface Quality (TFSQ) index, TFSQ
area and auto Tear Break-Up Time were obtained using Medmont E-300 at
baseline (naked eye condition) and 25 minutes after each contact lens insertion.
Results showed refractive sphere and cylinder were, respectively, −1.36 ± 1.04 D
(ranging from −6.00 to −0.25 D) and −0.23 ± 0.30 D (ranging from −0.75 to 0.00
D). Greater pre-lens tear instability (larger TFSQ and TFSQ area values) was

29
found with the dual-focus lens than the mono focal lens. Auto Tear Break-Up
Time was greater at baseline than with each of the contact lenses. This study
concluded that a slight reduction in short-term pre-lens tear film stability was
found in the dual-focus design in comparison with the mono focal lens, and
contributing to the worsening of visual performance and comfort during dual-
focus contact lens wear.40

30
 CHAPTER 3
OBJECTIVES

3.1: OBJECTIVES

Objective of the study was

1. To evaluate tear film breakup time among contact lens users.

31
3.2: OPERATIONAL DEFINITIONS

CONTACT LENS:
Contact lenses are thin, clear plastic disks that people wear in eye to improve
vision.it is an optical device. Contacts float on the tear film that covers cornea.8
TEAR FILM: The tear film is a thin fluid layer ocular surface. It is responsible
for ocular surface comfort, mechanical environmental and immune protection,
epithelial health and it forms smooth refractive surface for vision. The tear is a
three-layered structure superficial oily, middle aqueous and mucous layer at the
base.4
TEAR FILM BREAKUP TIME:
Tear break-up time also known as TBUT, it is the time taken for the first dry spot
to appear on the cornea after a complete blink. TBUT measurement is an easy and
fast method used to assess the stability of tear film. It is a standard diagnostic
procedure in the dry eye clinics41.
DRY EYE:
Dry eye is a painful ocular condition that could be caused by regularly prescribed
drugs, systemic inflammatory disorders and localized eye problems. It is
curable.42

32
 CHAPTER 4
MATERIAL AND METHODS

4.1: Study Design: This study was a Cross Sectional Study.

4.2: Study Settings: This study was carried out in E. Plomer and Sight On optics

4.3: Duration of Study: This study was conducted from FEB 2022 to MAY
2022. It was completed in four months after synopsis approval.

4.4: Sample Size: A sample of 93 patients using contact lens enrolled in this
study.

4.5: Sampling Technique: Non-Probability Convenient Purposive Sampling

technique was used in this research study.

4.6: Sample Selection:

4.6.1: Inclusion Criteria:

 Age group 18-30 years, both genders were included who wanted to
participate who uses contact lenses.
 Patients who have been using lenses for 2-5 years and use them for 4-8 hours
a day were included in this study.
 Only Soft contact lens users were included.

4.6.2: Exclusion Criteria:

 Hard contact lens users were excluded

 Subjects with the history of using Scleral contact lens users were excluded.

 Patients suffering from pathologies of cornea and conjunctiva were excluded

from this study.

 Patients with Sjogren’s syndrome were excluded.

33
 Individuals with ocular surgeries were excluded from the study.

 Patients with any systemic disease were not enlisted in this study.

4.7:Equipment:

 Snellen visual acuity chart was used for visual acuity measurements.
 Alcaine eye drops are used to numb the eye
 Normal saline was used to moistens fluorescein strip.
 Sodium Fluorescein ophthalmic strips was used to stain eyes.
 Slit lamp biomicroscope was used for evaluation of tear film.
 For measuring time taken by the tear film to break we used stop watch

34
 4.8 ETHICAL CONSIDERATIONS

The rules and regulations set by the ethical committee of university of Lahore
followed while conducting the research and the rights of the research participants
were respected.

 Written informed consent (attached) was taken from all the participants.
 All information and data collection was kept confidential.
 Participants were remain anonymous throughout the study.
 The subjects were informed that there are no disadvantages or risks on the
procedure of the study.
 They were also be informed that they will be free to withdraw at any time during
the process of the study.
 Data was kept in under key and lock while keeping keys in hand. In the lap top it
was kept under password

35
4.9: DATA COLLECTION PROCEDURE

1. Method for Collection Of Data

Data has been collected by clinical examinations and using self-designed Performa.93
Subjects from E.plomer and sight on optics has been enrolled in this study and they
were using contact lens from almost 2 to 5 years and 4 to 8 hours a day we had taken
measurements based on numerical data to evaluate the TBUT among contact lens
users for the assessment of tear film stability.contact lens users visited for their follow
up visit. We introduced our selves to our subjects and explained whole procedure,
Informed consent was taken by every subject.,with their permission we took their
ocular history, systemic history and contact lens history which includes duration of
contact lens use, daily hours of use and use of lubricant. Those who fulfilled our
inclusion criteria we measured their visual acuity first monoocularly then binocularly
by using Snellen chart, we did other ocular assessments with the help of slit lamp
biomicroscope then tear film break up time was measured on slit lamp after numbing
subject’s eyes by alcaine eye drops .We used normal saline to moisten the fluorescein
strips and then applied to inferior cul-de-sac of contact lens users and after frequent
blinking we checked the tear film breakup time with the help of slit lamp and stop
watch we noted the time as first break appeared in tear film precise measurements of
tear film break up times were documented we mentioned average TBUT on our self
design form. We advised lubricant eye drops to our subject who were showed
abnormal tear film break up time and advised to discontinue use of contact lens for
few days in patient with severe dry eye, TBUT ≤ 5 seconds.

Identification of the study variables

Outcome measurement:
 Evaluation of tear film breakup time among contact lens users

36
Variables:
1.independent variables:
 Age
 Gender
 Purpose of use
 Use of lubricant
 Duration of use
 Daily hours of use

2.Dependent variables:

 Tear film breakup time

37
 4.10: DATA ANALYSIS PROCEDURE
Statistical package for social sciences(SPSS) software version 25.0 for
data analysis was used in this research.

38
 4.11: GANTT CHART

Activity
01 02 03 04

Data collection

Data analysis and

interpretation

Thesis compilation

Thesis submission

39
 CHAPTER 5
RESULTS

5.1: Frequency Distribution Of Gender

GENDER FREQUENCY PERCENTAGE

52 56
Male
41 44
Female
93 100.0
Total

Table 5.1.1: frequency distribution of gender

The table 5.1.1 shows that total number of subjects were 93 out of which 52(66%)
were males and 41(44%) were female.
70
56%
60

50
52 44 %
40

30
41 female

20

10

0
Male female

Figure 5.1.1: frequency distribution of gender

40
The figure 5.1.1 shows that total number of subjects were 93 out of which
52(66%) were males and 41(44%) were female.

5.2: Frequency Distribution Of AGE

AGE Frequency Percent

18-23 49 52.7
24-35 44 47.3
Total 93 100.0

Table 5.2.1 frequency distribution of age

The table 5.2.1 shows that frequency distribution between age group 18-23 (53%)
and the age group among 24-35(47%).

54.0
53.0 52.7%
52.0
51.0
50.0 49
49.0 Percent
48.0 47.3%
47.0
46.0 44
45.0
44.0
18-23 24-35

Figure 5.2.1 frequency distribution of age

The figure5.2.1 shows that frequency distribution between age group 18-23
(53%)and 24-35(47%) age group.

41
5.3: Frequency Distribution Of Purpose Of Use Of Contact Lens

Purpose of use Frequency Percent

Cosmetic
32 34.4

Refractive
61 65.6

Total
93 100.0

Table 5.3.1: frequency distribution of purpose of use

The table 5.3.1 shows that frequency distribution of purpose of use of contact lens total
number of subjects were 93 from which 32 (34%)subjects were using contact lens for
cosmetic purpose and 61(66%) subjects were using them for refractive purpose.

70.0 65.6%
60.0

50.0

40.0
61
34.4%
30.0 Percent
32
20.0

10.0

0.0
Cosmetic Refractive

Figure 5.3.1: frequency distribution of purpose of use

42
The figure 5.3.1 shows that frequency distribution of purpose of use of contact
lens, total number of subjects were 93 from which 61(66%) subjects were using
TEAR FILM
INSTABILITY Frequency Percent
Normal 64 68.8

Abnormal 29 31.2

Total 93 100.0

them for refractive purpose while other 32 (34%) subjects were using contact lens
for cosmetic purpose.
5.4: Frequency Distribution Of Tear Film Instability

Table 5.4.1: frequency distribution of tear film instability

The table 5.4.1 shows that 64 (69%) out of 93 subjects had normal tear film break
up (stable tear film) time while 29 (31%) subjects had abnormal tear film break up
time (instable tear film).

43
 Frequency
Subjects Percent
Lubricant users 65 70%
64
Lubricant non users 28 30%

Total 93 100.0

80.0

70.0 68.8

60.0

50.0

40.0
31.2 Percent
30.0

20.0 29

10.0

0.0
Normal Abnormal

Figure 5.4.1: frequency distribution of tear film instability

The figure5.4.1 shows that 29 (31%) out of 93 subjects had instable tear film by
showing abnormal tear film break up time on the other hand 64 (69%) had normal
tear film break up (stable tear film) time.

6.1: Frequency Distribution Of Use Of Lubricant.

44
Table 6.1.1: frequency distribution of Use of Lubricant.

The table 6.1.1 shows that 65 (70%) out of 93 subjects were using lubricant eye
drops in their daily routine while only 28 (30%) were not using lubricants.

80
70%
70
60
50
40
Percent
30%
30
20
10
0
Lubricant users Lubricant non users

Figure 6.1.1: frequency distribution of Use of Lubricant.

Figure 6.1.1: shows that 65 (70%) out of 93 subjects were using lubricant eye
drops in their daily routine while only 28 (30%) were not using any lubricant.

7.1: Descriptive

45
 Discriptives Age Duration of Daily hours Tear film
use of use breakup
time
Mean±standard 23 ± 1.59 4.34 ± 0.71 4.74 ± 0.80 11.7 ± 2.3
deviation
Minimum 20 yrs 2y 4 hrs 6 sec
Maximum 26 yrs 5y 8 hrs 19 sec

Table 7.1.1: Descriptive

Table 7.1.1: shows descriptive of age, duration of contact lens use, daily hours of
contact lens use and tear film breakup time of contact lens users. Mean age of
subject were 23 ± 1.59, mean contact lens duration of use was 4.34 ± 0.71, mean
daily hours of use was 4.74 ± 0.80And their mean tear film breakup time was 11.7
±2.3.

46
 CHAPTER 6
DISCUSSION
A study was performed by Kaido et al in 2020, to evaluate the tear film dynamics
of soft contact lens induced dry eye. Study was conducted on 17 right eyes of soft
contact lens users (11men, 6 women; mean age 36.8+_8.3 years; range 24-57
years. Participants was divided into two groups depending upon the presence of
dry eye symptoms. 10 eyes were found symptomatic and 7 eyes were
asymptomatic of dry eye. Soft contact lens induced dry eye was associated with
tear dynamics only while wearing soft contact lens.36

In our study the percentage of contact lens users having tear film stability was
greater than those having instable tear film. We evaluated the Tear Film Break Up
Time in contact lens users. This cross-sectional study was conducted on 93
contact lens users. Out of which 52 (56%) were males and 41 (44%) were
females. The age group between 18-23 years were 49 (52.7%) and 24-35 were 44
(47.3). Contact lens users using for the purpose of cosmesis were 32 (34.4%)
while for the purpose of refractive error correction were 61(65.6%). Duration of
use of contact lenses were 2 years 1 (1.1%), 3 years 10(10.8%) 4 years 38(40.9%)
and 5 years 44 (47.3%). Daily hours of use of contact lenses were 4 hrs 40
(43.0%),5 hrs 41 (44.1%), 6 hrs 9 (9.7%),7 hrs 2 (2.2%), and 8 hrs 1 (1.1%).
Contact lens users divided on the base of age 20 years (5.4%), 21 years (17.2%),
22 years (14.0%), 23 years (16.1%), 24 years (28 %), 25 years (16.1%), and 26
years (3.2%). Tear film stability was evaluated by TBUT and it was found that
tear film was stable in 64 (68.8%) and tear film instability was found in 29
(31.2%).

47
Moreover in 2016, a study was performed by Zaidi et al to study the effect of soft
contact lens wear on tear film break up time . This descriptive observational study
was conducted on 30 participants with mean age of 24.5 ±5 years. All participants
were females and were using contact lens more than 3 months with no known
pathology. 60% participants were wearing refractive error correction lenses and
40 % were wearing cosmetic lenses. Only 6.67% had marginal tear film break up
time out of 30 participants and none of the shown dry eye.33.33% extended lens
wearers had reduced Tear Film Break Up Time as compared to disposable and
daily wearer of contact lenses. Contact lens wearer from 9-12 years had reduced
Tear Film Break Up Time as compared to using lens from 3-6 month. Conclusion
was that duration of contact lens wear increased, Tear Film Break Up Time
decreased. Extended wear contact lens users had more chance to develop
decreased Tear Film Break Up Time.5
Another study was conducted in 2006 by Nichols et al to examine the tear film,
contact lens, medical, and patient-related factors associated with self-reported
contact lens related dry eye. In this cross-sectional study Four hundred fifteen
contact lens wearers were recruited in larger phase. A variety of tear film, contact
lens, patient related factors were examined in relation to dry eye. 415 were
enrolled, the data from 360 were used in this analysis The average age was
31.1±11.5 years, 245 (68%) participants were female, and 55.3% were classified
as having contact lens–related dry eye via self reported. Overall, 327 (90.8%)
were hydrogel lens wearers and 33 (9.2%) were gas-permeable lens wearers.
Several factors were shown to be related to dry eye status. There were 199
(55.3%) classified with dry eye on questionnaire and 161 (44.7%) participants
classified without dry eye by self-report. Conclusion was that contact lens wearers
depended on tear film stability including the production and maintenance of the
constituents of its layers. Environmental condition, lens parameters, tear film
factors and wearing schedules may impact the tear film.43

48
7.1:CONCLUSION :

In our study it was concluded that 68.8% of contact lens users were having
normal tear film breakup time while 31.2% having abnormal tear film breakup
time.

49
7.2:RECOMMENDATION.

50
7.3:LIMITATION

51
 CHAPTER 8
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56
 CHAPTER 9
ANNEXURE
9.1: Consent Form
You are invited to participate in a research study conducted
AYESHA SHARIF 70091417
ABDUL-RAOOF 70091435
HAMZA KHALIL 70091402
MUHAMMAD NAVEED QADIR 70091383
MOHAMMAD RASHID AMIN 70091382
The purpose of this research is to evaluate the “TEAR FILM BREAKUP
TIME AMONG CONTACT LENS USERS
Risks and Discomforts
There will be no known risks associated with this research.
Potential Benefits
we will identify if your contact lens is affecting your tear film which will help you
to know your eye condition after long term use of contact lens.
Protection of Confidentiality
We will do everything we can to protect your privacy. Your identity will not be
revealed in any publication resulting from this study.
Voluntary Participation
Your participation in this research study is voluntary. You may choose not to
participate and you may withdraw your consent to participate any time. You will
not be penalized in any way should you decide not you participate or to withdraw
from this study.
CONSENT
I have read this consent form and have been given the opportunity to
ask questions. I give my consent to participate in this study.

Participant’s Signature __________________ Date: ____________________

57
 ‫تحقیقمیں شرکت کا دعوت نامہ‬

‫‪-‬عنوان‪ :‬کانٹیکٹ لینس استعمال کرنے والوں میںآنسو فلم کے وقفے کے وقت کا جائزہ‬

‫نقصانات اور تکلیف‪ :‬اس تحقیق سے کسی قسم کے نقصان یا تکلیف کا اندیشہ نہیں ہے ۔‬

‫ممکنہ فوائد‪ :‬آپکو ایک اہم تحقیق میں حصہ لینے کا موقعہ دیا جاۓ گا۔‬

‫رازداری کا تحفظ‪ :‬ہم آپ کی معلومات کے تحفظ کے لیے وہ سب کچہ کریں گے جو ہم کر سکتے‬

‫ہیں۔ تحقیق کے متعلق اکٹہی کیی گيی تمام معلومات کو انتہا ئی خفیہ رکھا جاے گا۔ ڈیٹا انٹری اور‬
‫تجزیے کے دوران آپ کے متعلق وہ تمام معلومات جن سے آپ کی شناخت ہو سکتی ہو کو ختم کر‬
‫دیا جاے گا۔ اس تحقیق کے نتیجے میں شائع ہونے والی کسی بھی اشاعت میں آپ کی شناخت کو‬
‫ظاہر نہیں‪ :‬کیا جاے گا۔‬

‫رضاکارانہ شمولیت ‪ :‬ا‪:‬س‪ :‬ت‪:‬ح‪:‬ق‪:‬ی‪:‬ق‪:‬ی‪ :‬م‪:‬ط‪:‬ا‪:‬ل‪:‬ع‪:‬ہ‪ :‬م‪:‬ی‪:‬ں‪ :‬آ‪:‬پ‪ :‬ک‪:‬ی‪ :‬ش‪:‬ر‪:‬ک‪:‬ت‪ :‬ر‪:‬ض‪:‬ا‪:‬ک‪:‬ا‪:‬ر‪:‬ا‪:‬ن‪:‬ہ‪ :‬ہ‪:‬ے‪:‬۔‪ :‬آ‪:‬پ‪ :‬ک‪:‬و‪:‬‬
‫ش‪:‬ر‪:‬ک‪:‬ت‪ :‬ن‪:‬ہ‪ :‬ک‪:‬ر‪:‬ن‪:‬ے‪ :‬ا‪:‬و‪:‬ر‪ :‬ک‪:‬س‪:‬ی‪ :‬ب‪:‬ھ‪:‬ی‪ :‬و‪:‬ق‪:‬ت‪ :‬پ‪:‬غ‪:‬ی‪:‬ر‪ :‬و‪:‬ج‪:‬ہ‪ :‬ب‪:‬ت‪:‬ا‪:‬ن‪:‬ے‪ :‬ا‪:‬س‪ :‬ت‪:‬ح‪:‬ق‪:‬ی‪:‬ق‪ :‬م‪:‬ی‪:‬ں‪ :‬ش‪:‬م‪:‬و‪:‬ل‪:‬ی‪:‬ت‪ :‬ک‪:‬و‪:‬‬
‫چ‪:‬ھ‪:‬و‪:‬ڑ‪:‬ن‪:‬ے‪ :‬ک‪:‬ا‪ :‬ا‪:‬خ‪:‬ت‪:‬ی‪:‬ا‪:‬ر‪ :‬ہ‪:‬ے‪:‬۔‪ :‬ش‪:‬ر‪:‬ک‪:‬ت‪ :‬ن‪:‬ہ‪ :‬ک‪:‬ر‪:‬ن‪:‬ے‪ :‬ی‪:‬ا‪ :‬ا‪:‬س‪ :‬م‪:‬ی‪:‬ں‪ :‬ش‪:‬م‪:‬و‪:‬ل‪:‬ی‪:‬ت‪ :‬ک‪:‬و‪ :‬چ‪:‬ھ‪:‬و‪:‬ڑ‪:‬ن‪:‬ے‪ :‬ک‪:‬ی‪ :‬ص‪:‬و‪:‬ر‪:‬ت‪:‬‬
‫م‪:‬ی‪:‬ں‪ :‬آ‪:‬پ‪ :‬ک‪:‬ے‪ :‬خ‪:‬ال‪:‬ف‪ :‬ک‪:‬و‪:‬ئ‪:‬ی‪ :‬ک‪:‬ا‪:‬ر‪:‬و‪:‬ا‪:‬يی‪ :‬ن‪:‬ہ‪:‬ی‪:‬ں‪ :‬ک‪:‬ی‪ :‬ج‪:‬ا‪:‬ے‪ :‬گ‪:‬ی‪:‬‬

‫درجذیلمعلوماتتحقیقمیںشاملہونےوالوںکےلیےپڑھیںاورانکاجوابدیےگیےخانوںمیںدرجکریں‬
‫‪‬‬ ‫میں نے معلوماتی شیٹ جو کہ تحقیق کی وضاحت کر رہی ہے کو سمجھ لیا ہےاورمجھے‬
‫تحققیق کے سواالت کرنے کا موقع دیا گیا تھا۔‬
‫‪‬‬ ‫میں سمجھ گیا‪/‬گيی ہوں کہ میری شرکت رضاکارانہ ہے اور یہ کہ میں کسی بھی وقت اپنا‬
‫ارادہ بدل سکتا‪/‬سکتی ہوں اور تحقیق سے دستبردار ہو سکتا‪/‬سکتی‬
‫میں سمجھ گیا‪/‬گیی ہوں کہ میرے جوابات خفیہ رکھے جاءیں کے۔ میں محقیقیين کو اس بات کی ‪‬‬
‫اجازت دیتا‪/‬دیتی ہوں کے وہ جوابات کو جانچ سکیں۔‬
‫میں سممجھ گیا‪/‬گی ہوں کے معلومات میرے نام کے بجاے نمبر کی صورت میں محفوط کی جائيں ‪‬‬
‫گی۔ تا کہ میں نتائج کی اشاعت کے دوران کسی بھی طرح سے شناخت نہ کیا جا سکوں۔ میں اس بات‬
‫سے رضامند ہوں کے جو معلومات مجھ سے لی جائہيں گی وہ تحقیق میں استعمال ہوں گی۔‬
‫میں اوپر بتایی گی تحقیق میں شامل ہونے کے لیے رضامند ہوں اور محقیقین کو اپنا پتہ تبدیل‪ :‬ہونے ‪‬‬
‫کی صورت میں مطلع کروں گا‪/‬گی۔‬

‫رضا مندی‪:‬ميں نے يہ اجازت نامہ پڑھا ہے اور مجھے سوال پوچھنے کا موقع ديا‬
‫گيا ہے۔ ميں اس سٹڈی ميں شرکت کے راضی ہوں۔‬

‫دس‪:::‬تخط____________________‬ ‫ش‪:::‬رکت کنن‪:::‬دہ‪ :‬ک‪:::‬ا ن‪:::‬ام __________________‬

‫___________ تاريخ‬

‫اجازت لينے والے کا نام ________________ دستخط ____________________تاریخ‬

‫‪58‬‬
 ‫____________‬
‫‪‬‬ ‫اس اجازت نامہ کی ايک نقل آپکو دی جانی چاہے۔ کرنے کا موقع دیا گیا تھا۔‬
‫‪‬‬ ‫میں سمجھ گیا‪/‬گيی ہوں کہ میری شرکت رضاکارانہ ہے اور یہ کہ میں کسی بھی وقت اپنا‬
‫ارادہ بدل سکتا‪/‬سکتی ہوں اور تحقیق سے دستبردار ہو سکتا‪/‬سکتی‬
‫میں سمجھ گیا‪/‬گیی ہوں کہ میرے جوابات خفیہ رکھے جاءیں کے۔ میں محقیقیين کو اس بات کی ‪‬‬
‫اجازت دیتا‪/‬دیتی ہوں کے وہ جوابات کو جانچ سکیں۔‬
‫میں سممجھ گیا‪/‬گی ہوں کے معلومات میرے نام کے بجاے نمبر کی صورت میں محفوط کی جائيں ‪‬‬
‫گی۔ تا کہ میں نتائج کی اشاعت کے دوران کسی بھی طرح سے شناخت نہ کیا جا سکوں۔ میں اس بات‬
‫سے رضامند ہوں کے جو معلومات مجھ سے لی جائہيں گی وہ تحقیق میں استعمال ہوں گی۔‬
‫میں اوپر بتایی گی تحقیق میں شامل ہونے کے لیے رضامند ہوں اور محقیقین کو اپنا پتہ تبدیل‪ :‬ہونے ‪‬‬
‫کی صورت میں مطلع کروں گا‪/‬گی۔‬

‫رضا مندی‪:‬ميں نے يہ اجازت نامہ پڑھا ہے اور مجھے سوال پوچھنے کا موقع ديا‬
‫گيا ہے۔ ميں اس سٹڈی ميں شرکت کے راضی ہوں۔‬

‫دس‪:::‬تخط____________________‬ ‫ش‪:::‬رکت کنن‪:::‬دہ‪ :‬ک‪:::‬ا ن‪:::‬ام __________________‬

‫___________ تاريخ‬

‫اجازت لينے والے کا نام ________________ دستخط ____________________تاریخ‬

‫____________‬
‫اس اجازت نامہ کی ايک نقل آپکو دی جانی چاہے۔‬

‫‪59‬‬
9.2: Questionnaire

EVALUATION OF TEAR FILM BREAKUP TIME AMONG CONTACT LENS USERS

DEPARTMENT OF OPTOMETRY AND VISION SCIENCES

Name: Gender:

Age: Occupation:

Residence:

History:

Contact lens history:

Duration of use:

Daily hours of use:

Visual acuity: OD: OS: OU:

Tear film breakup time: OD: OS: AVG:

60