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MODULE 5

QUALITY STANDARS IN
LENS SURGERY

 Objectives and Quality Plan


 Auxiliary Quality documents (Original Version).
Lens  Results analysis:
Surgery:  Informed Consent.
(Documents)
 Treatments:
 Preoperatives
 Postoperatives.
TABLA DE CONTENIDOS
1. INTRODUCTION……………………………………………………………….………….. 4

2. OBJECTIVES……………………………………………………………………………….….5

3. QUALITY ANALYSIS:……………………………………………………………….….6
 QUALITY INDICATORS.

4. INDICATIONS…………………………………………………………………………….…..7

 CATARACT

 LENS REFRACTIVE SURGERY (REFRACTIVE LENSECTOMY)

5. PREANESTHETIC EVALUATION………………………………………………….8
6. PREOPERATIVE……………………………………………………………………………...8

7. PREOPERATIVE EVALUATION……………………………………………………..….9

8. CORNEAL ASTIGMATISM CORRECTION………………………………………….10

9. ENDOPHTHALMITIS PROPHYLAXIS…………………………………………..……10

10. RISK PATIENTS: …………………………………………………………………………….11

 Use of intra and perioperative prophylactic measures

11. INDICATIONS OF BILATERAL AND SIMULTANEUOUS LENS


SURGERY……………………………………………………………………………..……….11

12. DIAGNOSIS AND INITIAL TREATMENT IN SUSPECTED ENDOFTHALMITHIS


………………………………………………………………………………………………………13
13. SURGICAL TECHNIQUE………………………………………………..…………….……17

14. INTRAOCULAR LENSES ……………………………………………………………...…...18

15. PRE AND POSTOPERATIVE INSTRUCTIONS AND TREATMENTS ………19

16. POSTOPERATIVE APPOINTMENTS……………………………………………………20

17. PATIENTS SATISFACTION SURVEY…………………………………………………...20

18. INFORMED CONSENTS……………………………………………....................................21


19. REFRACTIVE SURPRISES AFTER LENS SURGERY
……………………………………………….……………………………………………………..…21

APPENDANTS:

1. LOCS III System……………………………………………………22

2. Health Survey…………………………………………………….…23

3. ASA System…………………………………………………………25

4. Biometry Formulas……………………………………………….….26

5. Table for sulcus lenses……………………………………………….27

6. Nomogram for Opposite Clear Corneal Incisions (OCCI) and Limbal Relaxing
Incisions (LRI):…………………………………………………........29
A. LRI selection method………………………………….…30
B. Wallace Nomogram ……………………………………..31
C. Calculation of Limbal Relaxing Incisions (LRI)…………...32

7. Procedure for toric lens solicitation………………………...…………33

8. ESCRS protocol for Endophthalmitis prophylaxis ………………..…34

9. Protocol of surgical preparation in bilateral and simultaneous lens


surgery…………………………………………..…………………….35

10. Drug preparation and compounding for topical, intracameral and intravitreal
use…………………………………………...…………………….…..36

11. Operating Room sheet……………………...…………………………40

12. Drug preparation for intraoperative pupil dilatation in lens


surgery………………………………………………………………...41

13. Lens power calculation ……………………………………………….42

14. Instructions before surgery……………………………………………58

15. Postoperative instructions ……………………………………………59

16. Clinical discharge document model at the end of the follow up of a surgical
procedure ………………………….…………………………………..61

17. Satisfaction Survey………………………………….…………………62


INTRODUCTION

The present document has the purpose of establishing some objectives and common
criteria , supported by scientific evidence, which allows a uniform and joint action in lens surgery,
both in cataract management as in refractive lensectomy.
The plan statements: preoperative evaluation and preparation, indications, surgical
technique, types of intraocular lenses and their indications, treatments and postoperative follow
ups. Also the criteria for indication and execution for bilateral cataract or refractive lensectomy
surgery have been stablished. Also, tools have been design for quantitative and qualitative
evaluation of the medical activities developed at the corporation in this area.
As a consequence, a medical quality index will be made for identification and correction of those
established standard quality deviations, making a continuous improvement in the service we
provide to our patients.
The last objective of the quality plan is to accomplish a better and more homogenous attention
to the patient in each and every Vissum center, following quality criteria and using the actual
existing innovations for lens surgery which results are supported by scientific evidence.
Also, we have updated and review all of the informed consents that affect this area of our
specialty.
1.- Objectives

A. General Objectives:
1.- Improve the quality of life of the operated patient, improving their vision
quality and reducing to a minimum their glass dependence at all distances.

2.- Obtain the greater satisfaction of the operated patient at the end of his follow
up.

B. Specific objectives:
1- Cataract:
 Cataract surgery has today to get the objectives and finality of a
refractive surgery, with the greater efficacy and security as possible. For
that to happen is essential to do a surgery with the minimum trauma,
using the best possible incision and oriented to the best refractive result.
The objective to achieve is that the patient has an immediate recovery
to his normal life, making him independent of the use of glasses for far
vision, and as possible for near vision. The “Cataract” procedure does
not contemplate nor cover the costs of a retouch with refractive finality
during the post-operative course. It covers the correction of a surgical
induced anisometropia greater than 2 diopters.

2.- Refractive Lensectomy:


 With the same premises as cataract surgery, but looking for a
more accurate refractive result for far vision and a greater independence
or even the total elimination of near vision glasses.
In this procedure we have to take into account the possibility of a
corneal refractive surgery to optimize the refractive result. That
refractive retouch will be included in the cost of the surgery.

Objectives after the surgery: Target calculation or desired/programmed refraction


Cataract Refractive-phaco
-Post operative spherical equivalent <+/-1 +/- 0.50
-Post operative glasses astigmatism <+/- 1 <+/- 0.50

 Since the final objective is to obtain greater patient satisfaction, the procedure
will be completed, at the end of the post-operative follow up with a
SATISFACTION SURVEY to evaluate the quality perceived by the patient after
the surgery.
2. Analysis of Post-operative quality:
 Quality indicators.
The following medical quality index have been established:

 Post-operative visual acuity for far and near vision, with and without correction.
 Safety: Visual acuity with post correction / VA with pre correction
 Efficacy:
o Post far VA without correction / Pre VA with correction
o Post near VA without correction / Pre VA with correction
 90% of the cases with sphere of +/-1D
 90% of the cases with cylinder of >1D
 Post-operative average keratometry / Pre-operative average keratometry (<=1)
 Posterior average astigmatism in glasses <1.5D
 90% of clinical discharges made after more than 3 months of post-operative
follow up.
 Average refraction at the end of the discharge in 100% of the cases
o For far
o For near
 Complications
o Surgical
o Post-operative
 Does the patient need glasses? For what distance?
 Satisfaction survey at discharge, or between the 2nd and 3rd post-operative
month.
3. Indications
A. Cataract
 The procedure will be defined as cataract surgery under the following
circumstances:

1. Far visual acuity less or equal than 0.7, in photopic conditions and
without maculopathy or any other disease to justify it.
2. By age: over 70 years: When a lens surgery is programmed at this age,
regardless of the visual acuity. At this age, the concept of refractive
lensectomy will not be considered.
3. In function of the visual acuity quality referred from the patient, its
interference with his regular work, quality and life style.

 The type and grade of the opacities will be described using the Lens Opacities
Classification System (LOCS III) (See ANNEX 1).

B. Refractive Lensectomy

1) Myopic ametropia greater than -10 diopters with loss of accommodative capacity
greater than 2-2.5 diopters, in patients older than 50 years (especially when there is a
posterior vitreous detachment)

2) Hyperopic ametropia greater than +2 diopters, with loss of accommodative


capacity greater than 2-2.5 diopters in patients older than 50 years and between the
40 and 50 years, with loss of partial accommodation, and refraction greater than +3
diopters

3) In cases with lower refraction (<-10 and <+3) refractive corneal surgery or phakic
lenses will be preferred and only exceptionally a refractive lensectomy will be
indicated. Those indications will be made following the best medical criteria, in
function of the ocular clinical findings, personal and familiar background and the
patient’s visual needs.
4. Pre anesthetic Evaluation

Pre anesthetic evaluation: indicated when a local and regional anesthesia is planned
(medical criteria: depending on the patient characteristics and ASA), general anesthesia
regardless of the ASA classification and patients with ASA III and IV. Also the surgeries
of the underage patients.

There is not an anesthesiologist in every center, and sending all the asymptomatic patients
to a pre anesthetic evaluation may be expensive, inefficient and complicated. The
anesthetic evaluation the same day of the surgery or before it, guided by a health survey
may be a choice in the cases planned with topical anesthesia and patients with ASA I and
II. Other valid choice is the telephone interview used in the health survey (ANNEX 2).
The physical state evolution and anesthetic risk will be made with the Health Survey
exposed in the APPENDANT 2.

The surgery will always be made with the presence of an anesthesiologist, with
continuous monitoring and a venous access.

5. Pre-operative

Complementary testing: Not necessary in normal cases. Following the recommendations


of the American Society of Anesthesiology. (See ANNEX 3), the following are indicated

Analytics: complete blood count, coagulation, chemistry panel, with at least glycemia,
electrolytes, creatinine, BUN. Cholinesterase in children.
The anesthesiologist will consider the possibility of a pregnancy in every fertile woman
planned for general anesthesia.
The anesthesiologist in charge of the case will evaluate making a pregnancy test.

Electrocardiogram: (Men >45 years and women >55 years with 2 or more risk factors
for atherosclerosis. Always indicated when the patient refers heart rate alterations ASA
criteria). It’s decided as a general rule that always; for legal reasons, workability, because
it provides information sometimes unknown by the patient and for the sanitary culture of
the patients, because many of them think they don´t get the right attention if the test isn’t
required as a part of the pre anesthetic evaluation (many of them ask for the EKG to take
it home). It has a 6-month validity in absence of a pathology.

Chest X-ray: Just in cases when the anesthesiologist thinks is necessary.


6. Pre-operative evaluation
A. Biometry:
 Optic biometry choice: IOL Master ®. It has all the alternatives for the lens
calculation in every situation: pseudophakia, eyes with silicon oil and previous
refractive corneal surgery, etc.
 Or immersion ultrasonic biometry and contact biometry, in this order.
 See the details for the calculation formula to use. (Annex 4)
 A constant customization, customized for each center.
 Be aware of axial length <22 (Hoffer Q) and >26mm (SRK T), axial length
difference >0.3mm between both eyes, in myopias with axial length >26mm
check for staphyloma with B Ultrasound.
 Look for the more accurate calculation formula in the cases in Annex 4, for sulcus
implantation see monogram for power correction for sulcus Intraocular lens in
Annex 5 (it must be used in cases of intraoperative sulcus IOL implantation
secondary to capsular rupture).
 In complicated cases consult directly to the main direction.
Special cases

 Very large eyes, very short eyes, look the annex and as an
alternative use Holladay 2.
 After corneal refractive surgery (Holladay 2)
 Sulcus correction when there is a capsular rupture: (Annex
5)
 Pseudophakic lens calculation or Piggy Back
 Calculation in pediatric cataracts.

B. Keratometry:
 Attention with the IOL master refractive index and the manual or
automatic keratometers, they’re different.
 Use the values of automatic keratometry or manual, not the ones
in the IOL master or in the topography when we use an ultrasonic
biometry.
 Extreme K values (<40 and >47), compare the biometry results
with many formulas.
 For the power calculation of multifocal lens use the corneal
topography for the keratometry.
C. Pupillometry: mesopic and photopic keeping in mind the multifocal lens that are pupil
dependent but are defrayed by the companies.

D. Dominant eye: if we propose monovision or continuous vision, necessary for


accommodative IOL. Observations: write down in the history clinic next to the indication.
If it’s a very relevant observation put it as an entry advice. “PATIENT NOTES”.

E. PAM and interferometry indication in cases in which the macular function is doubtful,
amblyopia or Optic Nerve pathology.

F. Endothelial cell count indication suspicion of endothelial pathology after slit lamp
examination which reveals the case as a doubtful normal endothelium and in cases of
secondary implantation of anterior chamber lens, iris fixated or lens exchange.

7. Astigmatism correction: Corneal surgery or Toric IOL


 CORNEAL SURGERY: LIMBAL RELAXING INCISIONS: For making limbal
relaxing incisions we need a corneal topography and pachymetry. The astigmatism limit
correction at the cornea is 2 diopters. Greater astigmatism requires the use of toric lenses.

Look at the ANNEX 6, the Wallace Nomogram for the indications and realization of the
limbal relaxing incisions. Seeking the correction up to 2.25 diopters. They should be
placed 1mm from the limbus in the clear cornea for its best performance. The technique
and instruments are mentioned in the nomogram.

* CORRECTION WITH TORIC IOL: It’s considered in all cases with an astigmatism greater
than 2 Diopters.

8. ENDOPHTHALMITIS PROPHYLAXIS

 We recommend to follow the ESCRS recommendations. These are at the pre-operative


instructions and at the post-operative treatments in annex 8, making special relevance in
the use of 5% povidone iodine at least 3 minutes after surgery, minimize lashes in the
operative field with surgical drapes, and the use in all cases at the end of surgery of
intracameral cefuroxime, vancomycin or moxifloxacin (Vigamox) in case of allergic
reactions to penicillin and derivatives, in cases when there’s a well-founded suspicion of
high risk of infection and always that a bilateral simultaneous surgery is performed. For
the ocular surface asepsis, 1% povidone iodine will be used.

 High risk factors for endophthalmitis: ocular prosthesis in the contralateral eye, important
chronic blepharoconjunctivits, bilateral obstruction of the lacrimal with reflux and/or
secretion if pressuring the lacrimal sac, immunosuppression, severe atopy or a patient
with doubtful hygienic habits. In this cases the use of Moxifloxacin (Actira® 400mg) 1
pill a day, 1 day before, the day of the surgery and 3 days after will be considered
mandatory.

9. Patients with special risks:

Use of prophylactic measures during the intra and perioperative

1. Patients who have an increased risk of suffering postoperative cystic macular edema,
Epiretinal membrane, Retinal Vein Occlusion, uveitis, previous use of prostaglandins,
keep up for 8-12 weeks the treatment with topical monodose of Nonsteroidal anti-
inflammatory drugs

2. Floppy iris syndrome (FIS) associated with the actual and even previous use of
systemic alpha 1 agonists, specially Tamsulosin, confirm its use, their interruption
before surgery is not considered useful for preventing this complication.

Measures to have in mind during surgery: incision size the best as possible, valved
incisions in front of the iris root, use of bimanual MICS, intracameral adrenaline, iris
retractors or iris dilators may be useful, and high density viscoelastics.

10. Indications for bilateral and simultaneous lens surgery:


Recommendations about the procedure safety and performance at the operating room
facility

A. Indications for bilateral and simultaneous Cataract:

 Bilateral cataract with standard indication criteria of surgery according to


the VA and absence of contraindications.

 Unilateral cataract with an expected anisometropia >3D after surgery

 Consider it in all cases of cataract surgery or refractive lensectomy when


the patient wants or is a candidate for multifocal IOL.

 Any level of high myopia, when the eye to get surgery has amblyopia or a
bad visual potential because of preexisting myopic maculopathy.

B. Contraindications for bilateral and simultaneous cataract surgery:


 Bilateral cataract if it has a high surgical risk of suffering postoperative
endophthalmitis:

- Blepharitis resistant to treatment.

- Foreseeable poor compliance of postoperative care or treatment: Social


problems, psychiatric, etc.

 Refractive lensectomy: Idem. High myopia with axial length >27mm,


younger than 50 years, specific risks for retinal detachment and good
bilateral visual potential.

C. Preparation and specific preoperative prophylactic care for the


accomplishment of this surgery.
See ANNEX 9

BIBLIOGRAPHY:

Arshinoff SA, Bastianelli PA. Incidence of postoperative endophthalmitis after immediate


sequential bilateral cataract surgery. J Cataract Refract Surg. 2011 Dec;37(12):2105-14

11. Diagnosis and initial treatment in suspected endophthalmitis


At the suspicion of endophthalmitis proceed according to the next protocol:

1. Sample taking
For the diagnosis of endophthalmitis the vitreous sample is better than the aqueous
humor sample, since the percentage of positive PCR or cultures are greater in the
vitreous.

Take the sample from the vitreous whenever you can.

PROCEDURE:

Aqueous humor: puncture the anterior chamber with a 30G needle and withdraw
0.1ml as minimum.
Refer to the culture lab in the same capped syringe, from which the sample has been
taken.

Vitreous:
Puncture with a 23 or 25G needle and refer to the culture lab in the same capped
syringe, from which the sample has been taken.

If it is a vitrectomy, put a new cassette for the realization of the vitrectomy.


Once taken the sample, refer the cassette or its content in a sterile container to the
culture lab.

Do not refrigerate, some microorganisms aren’t viable if they’re stored at 4ºC.

MICROBIOLOGY LABORATORY PROCEDURE:


 Stains: Gram (bacteria), Calcofluor (fungi) and Giemsa (inflammatory cells)
 Culture:
 Swon in Thioglycollate and Sabouraud (keep for 21 days in case of
P. acnes)
 It there’s enough sample, swoon in blood agar and chocolate agar
 PCR: Storage one drop (50 microliters) in a sterile probe for PCR at 4ºC.

Refer the sample of aqueous humor or vitreous at a room temperature to a


specialized laboratory, immediately through a messenger, or storage it for no
more than 5 days and send it to the laboratory corresponding of each clinic.

2. Treatment:
The compounding and preparation of the drugs that are recommended are detailed at
the Annex 10.

1.1. Treatment of acute bacterial endophthalmitis:


Intravitreal:
 Vancomycin 1mg/0.1ml
 Ceftazidime 2mg/0.1ml or Amikacin 400 microgram/0.1ml
 Preservative free dexamethasone 400 microg/0.1ml

Puncture with a 30G needle, using different syringes, through a slow injection at the central
vitreous. Dilute 50% in a vitrectomized patient.

Systemic:
 Oral Moxifloxacin 400mg/day. ACTIRA (Bayer), Proflox (Esteve)

Topic:
 Ciprofloxacin 3mg/ml every 4hrs. Oftacilox (Alcon), Ciprofloxacin (Lepori).
 Dexamethasone 1mg/ml every 4hrs. Maxidex (Alcon), Colircusí
dexamethasone(Alcon).
 Atropine 0.5% every 12hrs.

When the antibiogram is known modify the treatment if necessary.


2.2. Treatment of chronic bacterial endophthalmitis:

When there is a suspicion of chronic endophthalmitis after taking the


microbiology sample administrate:
 Oral clarithromycin (500mg/12h) for two weeks. (Alter, Arafarma, Bexal,
Cinfa).

According with the microbiology report and the patient evolution, administrate an
intravitreal vancomycin injection (1mg/0.1ml)

If it isn’t resolved, perform a PPV (Pars Plana Vitrectomy) and a partial


capsulectomy + vancomycin (1mg/0.1ml)

If still no improvement: complete capsulectomy + IOL extraction.

Cases of chronic endophthalmitis, because of their singularity and slow evolution


should be considered a differential diagnosis for fungical endophthalmitis and
each case will be individualized, according to medical criteria, to the more
convenient surgical decision.

References:
1: Roth DB, Flynn HW Jr. Antibiotic selection in the treatment of endophthalmitis: the
significance of drug combinations and synergy. Surv Ophthalmol. 1997; 41:395-401.
2: Lalwani GA, Flynn HW Jr, Scott IU, Quinn CM, Berrocal AM, Davis JL, Murray TG, Smiddy
WE, Miller D. Acute-onset endophthalmitis after clear corneal cataract surgery (1996-2005).
Clinical features, causative organisms, and visual acuity outcomes. Ophthalmology. 2008;
115:473-6.
3: Krause L, Bechrakis NE, Heimann H, Kildal D, Foerster MH. Incidence and outcome of
endophthalmitis over a 13-year period. Can J Ophthalmol. 2009; 44:88-94.
4: Abreu JA, Cordovés L. Chronic or saccular endophthalmitis: diagnosis and management. J
Cataract Refract Surg. 2001; 27:650-1.

2.3. Treatment for fungal endophthalmitis

When you get the positive results for fungi detection by classic microbiology or PCR,
the first choice treatment should be a combined therapy: Intravitreal + oral.

If the causative agent is a yeast:


 Intravitreal Amphotericin B (5 microgram / 0,05 ml)
 Oral ketoconazole 200-400mg/day (Ratio farm, Panfungol or Fungarest
comprimidos)
 A PPV (Pars Plana Vitrectomy) is recommended.

If the causative agent is a filamentous fungus:


 Intravitreal Voriconazole (100 microgr / 0,1ml)
 Oral Voriconazole 200mg/12h. (VFEND® tablets. Because this is a drug for
hospital use, it should be obtained through the drugstore at each center.)
 A PPV is recommended.

When the causative agent is known the treatment will vary according to the species
causing the infection or antibiogram, if it’s available.

There’re known drug resistances according to the specie (for example: Fusarium sp is
resistant to fluconazole, Scedosporium Apiospermum is resistant to Amphotericin B,
Fusarium Solani is resistant to most of the Polyenes and Azoles).

If the anterior chamber is affected, add to the treatment:


 Voriconazole (100 microgr / 0,1ml) intracameral injection
 Topical Treatment:
 If it’s a yeast: Topical Amphotericin B (2mg/ml)
 If it’s a filamentous fungus: Topical Natamycin (5%)

Avoid corticoids as much as possible.


The diagnosis of suspicion of fungic endophthalmitis forces us to rule out the
differential diagnosis of chronic endophthalmitis, previous to the use of the antifungals
aforementioned, given its toxicity potential.

Maintain treatment for at least 2 months, after this period of time, maintain treatment
according to clinical judgment.

REFERENCES:

- Hariprasad SM, Mieler WF, Lin TK, Sponsel WE, Graybill JR. Voriconazole in the
treatment of fungal eye infections: a review of current literature. Br J Ophthalmol.
2008; 92:871-8.
- Gupta. Fungal endophthalmitis. Ophthalmology internacional. Summer 2009Vol 4
(2): 42-50
- Kernt M, Kampik A. Intracameral voriconazole: in vitro safety for human ocular cells.
Toxicology. 2009 28; 258:84-93.

NOTE: At annex 10 you can read the preparation protocols for the anti-infective drugs
and compounding for intravitreal drugs and eye drops.

12. Surgical Technique:


 Anastigmatic incisions: <2mm or temporal incisions and/or at the steepest
meridian that doesn’t induce cylinder or corneal aberrations.

 MICS surgery will be performed, defined as an incision equal or less than


2mm.

 Coaxial or biaxial techniques will be used for this surgery.

 As an alternative for MILS surgery, a mini-incisional surgery will be


performed (Coaxial phacoemulsification with 2.2mm incisions).

It’s obligatory to report the details of the surgical procedure in the surgical
intervention protocol. Look for the contents to report at ANNEX 11.

Attitude towards astigmatism correction; use of corneal surgery and toric


IOL. Annex 6.
Vissum corporation stands as a specific objective the correction of astigmatism
during cataract surgery.
For that it will employ:
- Clear corneal opposite incisions: Up to 1.5D
 They will be oriented by the corneal topography
- Limbal relaxing incisions: Up to 2.25 diopters
 They will be oriented by the corneal topography
 Annex 6, it can be realized with a calibrated blade at 600 microns
and with the annexed nomogram.
- Toric lenses: For astigmatism >2.25 diopters

NOTE: Alternative intraoperative intracameral mydriasis use (SEE ANNEX 12)

13. Intraocular lenses.


 As a general rule IOL’s with neutral aspheric optics will be used,
implantable for incisions sub 2.2mm.
 It’ll depend on the used technique and the patients characteristics (previous
refractive surgery, aberrometry, etc.) the neutral aspheric lenses (aberrations
free) provide a better visual quality to all patients in general, except for those
over 70 years and/or with photopic pupils less than 3mm, so they will be the
lenses of election at VISSUM corporation.
 All cases with astigmatism of 2 or more diopters will be corrected with a
toric intraocular lens.
Intraocular lens models selected for use at Vissum Corporation
1. Spheric Monofocal: they’ll be used just for sulcus implantation or
“Piggy Back”. The lens of choice will be the MA 60 Alcon model.
2. Aspheric monofocal: SN60 (aspheric), IQ (aspheric) from Alcon. The
use of aspheric IOLs placed in sulcus will be avoided because of the
possibility for tilt or decentration that will negatively affect the optic
performance of aspheric IOL (See Annex 5). Table for power
conversion from bag to sulcus.
3. Multifocal: AcrySof Restor SN +3, MPlus +3 de Topcon, ATlisa
TRI839MP from Zeiss y Lentis MPlus x from Topcon.
4. In case of capsular rupture, the second eye will have a bifocal three-
piece lens Alcon MA-60 will be implanted at the sulcus, assess
centration and iris suture.
5. Toric: Toric AcrySof with 2.2.mm incisions.
At the annex 7 a formulary for toric lens request is attached.
6. Hypernegative aspheric (aberration correcting). Acrysof IQ, is
the most complicated indication and forces for a previous corneal
aberration study (customization) indicated specially for patients
with previous corneal surgery.
7. Accommodative: Vissum corporation doesn’t use at this moment
these lenses because of the insufficient results they provide.

Indications and Contraindications of multifocal lenses


 Rule out any pathology that affects contrast sensibility: macular
pathology, corneal opacities, previous corneal refractive surgery,
high myopia, glaucoma, suspicion of previous amblyopia.
 The corneal astigmatism must be less than 1.5 -2 diopters (handle it
according to the aforementioned criteria). For cases of greater
astigmatism, consider the use of Toric Acrilisa (must be asked with 6
weeks anticipation)
 Be sure about the patient expectation regarding the result.
 Not adequate for pilots, night drivers or people who wish to have an
excellent night vision, or in poor light conditions.
 Always look for emmetropia and consider the possibility of a
postoperative retouch with Lasik.
 Use only in corneas with low levels of high order aberrations, with a
corneal HOA total <0.6 – 0.9.
 Never guarantee the total elimination of near glasses.
Special cases:
- Intraocular lens calculation after corneal refractive surgery. Look Annex 13.
 Capsular tension ring in myopic and Young patients with plate lens
design, absence of capsular support and piggy back Zein Lisa three
piece multifocal.
14. Pre and postoperative instructions and treatments.
1- Preoperative instructions and treatment for the patients (Annex 14)
2- Postoperative instructions and treatment for the patients (Annex 15)
All of the printed treatments will have the next format:
 Patient Name and history clinic number at the top.
 Name and scanned signature of the surgeon at the bottom.
 There’ll be an aloof for the postoperative appointment.
 Avoid handmade corrections in already printed treatments. Any
treatment modification should be made in a different prescription,
typewritten and signed by the surgeon in charge of the case, it will
be annexed to the postoperative format. Any modification made
have to appear at the patient’s history chart, writing them at the
surgery observation space.

15. Postoperative appointments and clinical discharge.


 First visit: 24/48hrs after surgery, visual acuity, anterior
biomicroscopy and intraocular pressure

 Second visit: 15 days -1 month (with the exception in complicated


cases) VA, near vision correction, anterior biomicroscopy and
Intraocular pressure, autorefraction.

 Last visit with clinical discharge: 2.3 months, visual acuity, near and
far vision correction, biomicroscopy, intraocular pressure, and
satisfaction survey that will be given and collected at patient attention
department. It’s advisable to discharge the patient at the 2nd month
after surgery. THE CLINICAL DISCHARGE IS A DOCUMENT
THAT THE OPHTHALMOLOGIST MUST WRITE DOWN AND
PUT IT IN THE HISTORY CHART. THE PATIENT WILL GET
THE DOCUMENT SIGNED BY THE OPHTHALMOLOGIST (IT IS
NOT NECESSARY THAT THE PATIENT SIGNS IT). THE
OPHTHALMOLOGIST CAN GIVE A VERBAL DISCHARGE
AND IS NOT OBLIGATORY TO GIVE THE PATIENT A
DOCUMENT. (Look for the clinical discharge format after surgical
intervention at ANNEX 16).

 If the patient isn’t discharged, it has to be specified why.

16. Satisfaction Survey (Annex 17)


 It will be given to the patient when the date of the surgery is set by
customer attention department and it will be picked up at the last visit
 In case that the patient doesn’t get discharged, at the next visit that
may be between the 2nd and 3rd postoperative month, the
administrative staff in charge of the survey will ensure that it is done
before the patient is discharged and the type of procedure done to the
patient.
 It’ll be performed by the staff indicated by management.

17. Consent Form:


1. Cataract
2. Refractive phaco
3. Bilensectomy
4. Secondary lens implantation
5. Lens Exchange consent

6. Sulcus Multifocal lens consent

18. Performance at a significant residual defect after lens surgery.


A. After refractive lensectomy: Lasik will be used to correct all the defects that are
considered symptomatic and cause patients’ dissatisfaction. It will be made by
mechanical microkeratome (M2 or similar), following the usual criteria and
indication of Lasik. It should be discussed with the patient the convenience of
inducing monovision or not, if the patient doesn’t have a multifocal lens.
B. Cataract surgery cases: Any residual ametropia that is referred as a cause of
dissatisfaction by the patient. The patient satisfaction about the use of
complementary glasses should be made, and it will be a medical decision to
proceed with mechanical Lasik in cases when the astigmatism is superior to 1.5
diopters and the residual sphere superior to 1.5. Cases with an inferior magnitude
should be considered individually in every patient. In PRIVATE patients this
complementary procedure will not be billed. In patients with insurance coverage
this procedure, if needed will be billed as a complication (in example, YAG laser
treatment or similar).
C. Multifocal and accommodative Intraocular lens cases: The patient should
know that the procedure is less predictable. The correction with wave front is not
precise and should not be used.

Annex 1:

LOCS III SYSTEM

The LOCS III (The lens Opacities Classification System) version should be used to
document in the history chart the degree of cataract, putting a picture of the
Standard images at the wall or at any place of the program.
Annex 2: HEALTH SURVEY FOR EVALUATION AND USE OF
PREOPERATIVE ANESTHETIC.
The objective is to perform with safety and efficacy the preanesthetic consultation, in
which a nurse will participate by delegation of functions, tutored and after specific
training.
The preanesthetic evaluation will be done through a protocolled survey and an
anesthesiology consultation if necessary to evaluate the patients.
In Europe there are some initiatives certified by clinical guidelines and validated studies
that demonstrate the capacity of the nurse team in the preanesthetic evaluations of
surgical patients without associated pathologies and candidates to minor complexity
procedures (outpatients exclusively, ASA I and ASA II, adults, that won’t be subjected
into general anesthesia, complex or prolonged surgeries or with bleeding risk, or a chance
for admission for the immediate postoperative control) through protocolled interviews
supervised by an anesthesiologist.
Although an anesthesiologist will direct the preoperative study, it could be considered
as a multidisciplinary task that involves the personal staff in the aforementioned cases.
Possible health questionnaire and anesthesiologist consultation criteria may be the
following:

PROTOCOL I OF HEALTH SURVEY:


1. Name and last name
2. Age
3. Do you need a translator?
4. Do you have a family member of a friend that will join you?
5. Have you had a heart attack, infarct, angina pectoris or something similar?
6. Have you had palpitations, arrhythmias, shortness of breath, or chest pain?
7. Have you ever been told you have a heart murmur, rheumatic fever, or any cardiac
valve problem?
8. Have you had heart or lung surgery?
9. Have you ever had shortness of breath?
10. Does your feet and ankle swell?
11. Do you have high blood pressure?
12. Do you need to sleep with more than one pillow?
13. Have you ever been admitted to the hospital?
14. Do you use any dental prosthesis or dentures?
15. Have you ever had surgery? With what kind of anesthesia?
16. Have you or any family member had problems with the anesthesia?
17. Do you have any problems for opening your mouth or does your jaw joint hurts when
you chew?
18. Have you ever had hoarse voice for more than a month?
19. When was the last time you had fever, chills, a cold, or bronchitis?
20. Do you smoke?
21. Have you ever had a hiatal hernia, hepatitis, jaundice, typhoid fever, malaria, hepatic
diseases, brucellosis, intestinal parasites?
22. Have you had blood in your stool or have vomited blood during the last year?
23. Have you had anemia?
24. Does your gums bleed easily; have you had any coagulation problems, important
hemorrhages, blood transfusions?
25. Do you have any allergies, drugs, pollen, food, metals or latex?
26. Do you have any kidney problem?
27. Do you have diabetes or high blood sugar?
28. Do you have thyroid problems?
29. Do you have epilepsy, paralysis, tremors, or any nervous system disease?
30. Do you have listening problems?
31. Make a list with the medications you use
32. Do you drink alcohol?
33. Do you use any type of drugs?
34. If you’re a fertile woman, are you pregnant or do you suspect you might be?
35. Do you consider anything else that the anesthesiologist would like to know?

PROTOCOL II HEALTH SURVEY:


Anesthesiologist consultation criteria:
 Morbid obesity
 Physical defects: dwarfism, abnormal facies, scoliosis…
 Suspicion of difficult airway
 Drug addict
 Previous severe allergic reaction
 Sintrom intake
 Asthmatic patients in treatment with one or more medications and/or inhaler, that may
need hospital admittance.
 Uncontrolled high blood pressure with two or more medications.
 Antiplatelet agents.
 INSULIN OR ORAL HYPOGLYCEMIC AGENTS.
 Any heart or respiratory condition referred in the health survey.
 Patients with any previous anesthetic complication.
 Patients with family members that have died during an anesthetic procedure without a clear
cause.
 Patients with history of malignant hyperthermia
 Patients with neoplasia

Annex 3:
ANESTHESIA RISK CLASSIFICATION SYSTEM American Society of
Anesthesiology (ASA)
Classification system used by the American Society of Anesthesiologists (ASA) to
estimate the risk that the anesthesia presents in various patients’ conditions.

Annex 4:
CRITERIA FOR THE USE OF INTRAOCULAR
LENS CALCULATION FORMULAS

CRITERIA Axial Lenght Axial Length Axial Length Axial Length


<22 mm 22 24.5 > 26 mm

1st
HOFFER-Q SRK-T SRK-T SRK-T
CHOICE

2nd HOLLADAY HOLLADAY HOLLADAY

CHOICE II

Annex 5:
TABLE FOR LENS POWER DETERMINATION WHEN IT HAS TO BE PLACED IN
THE CILIARY SULCUS AND IS CALCULATED FOR THE CAPSULAR BAG
(Posterior capsule rupture cases and other situations as Intraocular lens
Exchange)
Annex 6:

Opposite Clear Corneal Incisions (OCCI) and Limbal Relaxing


Incisions (LRI) Nomogram

Amount of Astigmatism to
Type of Incision
Correct

Simple axe steeper < 0.50D

OCCI of 3.2mm 0.50 a 1.0D

OCCI of 3.5mm
1.0 a 1.5D
LRI (Look at annex 6A)

ILR (Look at annex 6A) 1.5 a 2,0D

Considerations:

Keep in mind that when doing OCCI, one of the incisions will be used to perform the
phacoemulsification, so the surgeon will evaluate his comfort in function of the axis of
those incisions.
A -180º marking will be performed before surgery at surgery’s room the slit lamp
Marking the axis where the opposite incisions will be made have to be done before
initiating the surgery.
The incisions will be made 1mm from the limbus.
The opposite incision will be made 180º from the first incision before inserting the IOL.
If a MICS procedure is done, when inserting the IOL, the incision will be enlarged
according to the correction and then the confection of the opposite incision will be done.
Annex 6A: Limbal Relaxing Incision choice methodology.
1) Wallace LRI Nomogram(See Annex 6B)
2) Determine whether the astigmatism is with or against the rule.
3) Put the next data in the Nomogram:
a. Patients age
b. Astigmatism
4) The obtained value will be the degree of the incision and the number between
paracenteses indicates how many incisions have to be done at the steeper
meridian.
When using this Nomogram, the incision depth will be 600 microns.

5) As an alternative method and as a comparative way, the Limbal Relaxing Incisions


(LRI) can be used. http://www.lricalculator.com (See Annex 6C)
a. This calculator will give us LCR information in function of the location,
extension and predetermined depth of 600 microns.

* The incision will be made at 1mm from the limbus.


Annex 6B: Limbal relaxing incisions
Annex 6C: Calculation of Limbal Relaxing Incisions (LRI)
Annex 7:

Procedure to be followed by Centre management, through purchases, for requesting a


toric IOL.

PROCEDURE FOR TORIC LENSES SOLICITATION ( According to a document


corresponding to IMEXCLINIC company)
The procedure design from the Logistics Department goes as follows:
Step 1: Imex Clinic, will only accept orders by e-mail. For convenience and
especially quickness, it’s more effective to expedite those orders.
Step 2: Most part of the form must be completed, try to answer all of the solicited
data, since this is the only way the fabricant will do with security and success the
lens that is going to be implanted, plus, avoid delivery delays because of missing
data.
Step 3: Once the form is completed, it will be sent directly to the company of the
lens selected by you for the implantation.
Step 4 : You will be informed about the recommendations calculated by the
manufacturer (for that to happen, we’ll send those recommendations to the e-mail
address from which you sent the form or any other that you indicate). When
you’re comfortable with one of the recommendations, you’ll have to tell us which
one have you selected.
Step 5: Once receiving your replay with the recommendation selected, we’ll
proceed to do the petition to the manufacturer. From that moment on, the delivery
date will be of 8 weeks; because that’s the time it takes the fabrication of the lens.
Step 6: You’ll receive 2 intraocular lenses from the same power, this as a security
measure, if one of them breaks, falls, or any other problem. If you only want 1 unit,
you’ll have to specify it in the order.
The lens that has not been implanted must be returned to the Company. To facilitate
this last step, you’ll receive along with the lenses a label with all of our data and
telephone number so you can contact us, and an agency will pick it up.
Step 7: Both lenses will be charged. You will get a refund once the lenses that were
not used are received. Having to pay only the lens that was implanted.

Annex 8:
ESCRS Endophthalmitis prophylaxis guidelines:
1. Consider use of topical quinolone (levofloxacin* or Ofloxacin one drop four times
daily) or a topical combination of polymyxin B/bacithracin/neomycin for 24 or 48 hours
prior to surgery
2. And/or Apply topical quinolone (same type) to cornea and conjunctiva with one drop
one hour prior to surgery and one drop one half-hour prior to surgery
3. It is mandatory to apply one drop povidone iodine five per cent, or 10ml povidone
iodine five per cent on a sponge pad, or aq. chlorhexidine 0.05 per cent, to the cornea
and conjunctival sac for a minimum of three minutes prior to surgery, preferably this is
done in the preparation room.
4. Apply 10 per cent povidone iodine or 0.05 per cent chlorhexidine to the peri-orbital area
in the operating theatre as skin antisepsis
5. Surgeon washes hands with antiseptic soap solution (povidone iodine or chlorhexidine),
gowns up and wears sterile gloves and a mask. Check that theatre airflow is running and
that doors are closed
6. Apply surgical drapes and taping of eyelids to remove eye lashes from the
surgical field
7. Consider using foldable IOLs that can be inserted through a sterile injector
8. Apply 1mg cefuroxime in 0.1ml saline (0.9 per cent) by intra-cameral injection at the
end of surgery. In cases of penicillin allergy, refrain from its use. In a patient with high
risk of infection, substitute for intracameral Vancomycin (Look for preparation at the
Annex 10, item 3 “preparation of intracameral antibiotics”).
9. Re-apply topical quinolone (same type) at the end of surgery as one drop stat, one drop
five minutes later and one drop five minutes later again
10. Give post-operative topical prophylaxis with the same quinolone:
a. One drop every one to two hours on the day of surgery.
b. From the next day, give four times daily (six hourly) for one or two weeks if
scleral tunnel or sutured clear cornea incision was used

ANNEX 9: Preparation protocol for bilateral and simultaneous cataract surgery.


A. PREOPERATIVE PREVENTION
1. Protocolized topical prophylaxis
2. Use different anesthetic bottle, they will be identified by a “D” and a “I”.
3. Skin antisepsis with 10% povidone iodine
Two different gauze should be used for the skin antisepsis
4. Before going into the operating theater look at the patient’s eyes for any possible
conjunctivitis.
5. Irrigate the ocular surface with one drop of 1% Povidone Iodine 5 minutes after the
surgery.

B. INTRAOPERATIVE PREVENTION

1. Taping of eyelids to remove eye lashes from the surgical field


2. Use different bottles of 0.9% saline, mydriatic, intracameral antibiotic and viscoelastic
during surgery, identifying them with a “R” and a “L” that will be used to the
correspondent eye.

To prepare Cefuroxime as an intracameral antibiotic, dilute 250mg of Cefuroxime in 2.5ml of


saline (0.9% ClNa). The concentration of this dilution is 100mg/ml. After taking 1ml, the rest
of the solution can be refrigerated so it can be used latter that day. 1ml of the afore mentioned
solution, dissolved in 9ml of saline, getting a concentration of 10mg/ml. THESE
SOLUTION IS STABLE AT A ROOM TEMPERATURE FOR ABOUT 5 HOURS. For
each surgery take 0.1ml on a syringe, which has 1mg of Cefuroxime. Then it can be used
intracameral.
3. Separate completely the surgical tables, through the Custom Pack. Nothing has to be
transferred from one table to another.
4. The surgeon, nurse and/or instrumentalist have to change gloves.
5. Change of phaco tip in-between surgeries.
6. Instrumental change between each eye. Cleaning and instrument sterilization must be
done following the corporation’s protocols.
7. A last revision of the lens will be made between the circulating and the nurse /or
instrumentalist through the list that they have put in a visible zone.

C. END OF THE SURGERY:

1. Eye irrigation with one drop of 1% povidone iodine.


2. Cleaning of periocular skin with saline with different gauze
3. Initiate protocolized topical treatment

ANEXO 10:
Anti-infectious drug preparation and compounding
Drug preparation must be done under strict sterile conditions and in a pharmacy authorized for
that porpoise.

The preparation of the medications recommended in this document are detailed following the
next order:

1. Intravitreal
1.1. Intravitreal Amikacin
1.2. Intravitreal Amphotericin B
1.3. Intravitreal Ceftazidime
1.4. Intravitreal Dexamethasone
1.5. Intravitreal Vancomycin
1.6. Intravitreal or intracameral

2. Eye drops
2.1. Amphotericin drops
2.2. Natamycin drops

1. INTRAVITREAL MEDICATION.

1.1. INTRAVITREAL AMIKACIN (400 microgr/0,1 ml)

Endophthalmitis caused by sensitive germs (gram negative). As in all the aminoglycosides, it


causes retinal toxicity when it’s administered in the vitreous, but this toxicity seems to be less
than the one caused by tobramycin or gentamicin. One alternative is the use of intravitreal
ceftazidime.

Components:
 Amikacin vial 500 mg/2 ml
 Sterile Normal Saline
Preparation:
Withdraw in a 50ml syringe 40 to 45ml of saline. Withdraw 0.8ml of the amikacin vial, add it
to the 50ml syringe, mix well and complete it with saline. Fill through a 5 micron filter a 0.5ml
syringe.
Adjust the volume and close it. Pack it as a sterile product, protect from exposure to the light and
label it

Expiration: 24 h.
Conservation: Keep it away from the light and in the freezer.

1.2 INTRAVITREAL AMPHOTERICIN B (5 microgr / 0.05 ml)


Fungical Endophthalmitis.

Components:
 Amphotericin B vial 50 mg (Amphocil®)
 Water for Injection

Preparation:
Reconstitute an Amphocil vial with 10ml of water for injection. Withdraw 1ml from the
reconstituted vial in a 1ml syringe (A syringe). Withdraw 40-45ml of water for injection
in a 50ml syringe (B syringe). Add the content of the A syringe to the B syringe, mix well
and fill it with water for injection up to 50ml. Fill a 0.5ml syringe and dump air at 50
microliters, close it, pack it as a sterile product and label it.

Expiration: 24 h.
Conservation: Keep it away from the light and in the freezer.

1.3. INTRAVÍTREAL CEFTAZIDIME (2mg / 0.1ml)


Third generation cephalosporin active against Pseudomonas aeruginosa and other gram
negatives. Useful in ocular infections and corneal ulcers caused by sensitive germs. Given
its low retinal toxicity, it can be an alternative to the aminoglycosides administration.

Components:
 Ceftazidime 1G vial (Fortam®, Kefamin®)
 Water for injection
 Sterile Normal Saline

Preparation:
Add 9.4ml of water for injection to the ceftazidime vial. Mix it and maintain a needle in the
vial so it can be ventilated and avoid the overpressure of carbon dioxide that is form during
the reconstitution. Maintain a negative pressure in the vial during the manipulation.
Withdraw 2ml of the reconstituted vial in a 10ml syringe. Complete the syringe volume
with sterile normal saline. Mix well and through a 5 microns filter fill a 0.5ml syringe. Adjust
the volume up to 0.1ml, keep it away from the light and label it.

Expiration: 24 h.
Conservation: Keep it away from the light and in the freezer.

1. 4. INTRAVÍTREAL DEXAMETHASONE (400 microgr / 0,1 ml)

Glucocorticoid used widely as an anti-inflammatory agent. Since it’s commercialized as eye


drops, oral and parenteral presentation, the intraocular or subconjunctival administration
has to be considered as a second choice.

Components:
 Dexamethasone 4 mg (Fortecortin®) A

Preparation:
Open the dexamethasone bottle. Fill a 0.5ml syringe through a 5microns filter (0.22 microns if
you’re not working in a horizontal flow hood). Adjust the volume, close the syringe, pack it as
a sterile product, keep it away from the light and label it.
Expiration: 24 h.
Conservation: Keep it away from the light and in the freezer.

1.5. INTRAVÍTREAL VANCOMYCIN (1 mg / 0,1 ml)


Antibiotic active against Staphylococcus, group A, alpha hemolytic Streptococcus and
Streptococcus pneumoniae among other germs.
Its intravitreal use is reduced by endophthalmitis caused by sensitive germs. Must be used with
precaution because of the possibility of retinal toxicity.

Components:
 VANCOMYCIN 500 mg VIAL
 Sterile Normal Saline

Preparation:
Reconstitute vancomycin vial with 10 ml saline. Withdraw 2ml in a 2ml syringe and pass it to a
20ml syringe through the needle hub. Also add through the needle hub 8ml of saline. Allow an
air chamber in the syringe, cover and mix. Dump air and couple a 5 microns filter to the 20ml
syringe. Insert a needle to the filter and fill a 0.5ml syringe with the content of the 20ml syringe
through the hub. Make sure there are no air bubbles in the syringe, adjust the volume and close
it. Pack it as a sterile product, protect from exposure to the light and label it

Expiration: 96 hr., although its immediate use is recommended.


Conservation: Keep it away from the light and in the freezer.

1.6. INTRAVITREAL OR INTRACAMERAL VORICONAZOLE (100 microgr / 0.1 ml)

Second generation triazole antifungal with more power and spectrum than fluconazole.
Components:

 Voriconazole 200 mg VIAL (VFEND®)


 Water for injection

Preparation:
Reconstitute the voriconazole vial with 19ml of water for injection (a 10mg/ml solution is
obtained). Withdraw 5ml from the reconstituted vial and pass it through the needle hub with a
50ml syringe. Fill the syringe with saline. Cover and mix. Fill a 0.5ml syringe. Adjust the
volume (0.1ml) and close it. Pack it as a sterile product and label it.
Expiration: 24 h.
Conservation: Keep it in the freezer.
Observations: A volume increase regarding the dissolvent added is produced from reconstituting
the VFEND vial

2. EYE DROPS.
TOPICAL AMPHOTERICIN (2 mg / ml)

Fungic endophthalmitis and keratitis

Components:
 Amphotericin B vial 50 mg (Amphocil®)
 Water for injection
 Artificial tears TEARS NATURALE ® 10ML

Preparation:
Reconstitute Amphocil with 10ml of water for injection. Withdraw from the artificial tears bottle
4ml, using an insulin syringe (25G or smaller). Introduce the needle through the artificial tears
dropper hole. Without taking out the insulin syringe, take 4ml of the reconstituted vial of
Fungizone and add it into the artificial tears bottle. Mix well and close it. Keep it away from the
light and label it.

Expiration: 17 days.
Conservation: Keep it away from the light and in the freezer.

NATAMYCIN.

Fungic endophthalmitis and keratitis

Commercial: Natacyn ALCON.

Ask to the drugstore as a foreign medication (it comes from the United States of America)

Bibliography:

A. JM Alonso Herrero. “Medicine drug preparation and compounding” Díaz de Santos,


Edition, S.A. España.

Annex 11:
OPERATING THEATER SHEET
 Applied technique: Standard coaxial, micro coaxial, MICS, MicroMICS,
extracapsular, intracapsular, it may come as default
 Platform: Infinity, Stellaris, Millenium, Legacy, Accurus,
 Energy applied: Longitudinal Faco, Torsional faco, mixed, others, it may come
as default
 Hour meridian of the main incision
 Principal incision size: 0-1, 1-2, 2-3, 3-4, more than 4
 Parameters:
o Phaco time: seconds
o Phaco power: mj
o Effective Phaco Time
 Lens model: foldable with the lens that are used
 Suture: not if, it may come as default
o Just if suture: 1 suture, 2, 3 numerate, continuous
 Intracameral cefuroxime: Yes, no (yes by default)
 If not: if other, name the prophylaxis or without antibiotic
 Complications: no by default, if yes:
o Descemet detachment yes/ no, always no by default
o Capsular rupture yes/no (always no by default) if it’s yes:
 Vitreous loss yes/no (always no by default)
 Lens fragments into the vitreous (always no by default)
o Iris damage yes no (no by default)
o Others- uveal effusions Floppy Iris Syndrome
o Astigmatism correction by corneal surgery (no by default)
o Limbal relaxing incisions yes/no (no by default)
 Observations or commentaries.

Annex 12:
Drug Preparation pattern for intraoperative pupil dilatation
in Lens Surgery

1- ADRENALIN® amp. 1:1.000 can be used (1mg/ml, in anesthetics intracardial injection


preparation)
2- Mydriatic-anesthetic combination (Fidrane, Thea lab, France)
Intracameral use of 0,1-0,2ml of the following solution
1. 1ml of 1% cyclopentolate
2. 1,5 ml of 10% phenylephrine
3. 5 ml of 1% lidocaine
4. 2,5 ml of balanced salt solution

Annex 13:
IOL calculation norms after corneal surgery
Intraocular lens calculation posterior to refractive surgery

Patient Name _______________________


RE/LE

Data Required:

K1pre_______K2pre________Kpre(media)______

Prerefraction(Rpre)________ Pre Spherical equivalent (EEpre)________

Postrefraction (Rpost)(stable)___________ Post Spherical equivalent (EEpost)__________

Refraction difference= EEpre-EEpost

Refraction difference_______ = EEpre_____-EEpost_______

Topography central Kpost (central 2mm) =_________

IOL Master Axial Length /A-Scan___________

2nd Assumption: We know Rpre, Rpost y Kpost


A) Holladay Program
a) The same procedure as assumption 1.
3rd Assumption: We only know Kpost
1st assumption: We now Rpre, Kpre, Rpost and Kpost
A) Clinical history method
Kpost-corr = Kpre-EEepre + EEpost
Kpost= postoperative corrected keratometry
Kpre= preoperative keratometry
EEpre= Preoperative spherical equivalent
EEpost= Postoperative spherical equivalent
The EE values must be transformed to the corneal plane with the following formula:

EE corneal plan= EEgafas/1-(EEgafas*0.012)

Kpost-corr_____= Kpre_____-EEpre_____+EEpost_____
The Kpost-corr value can be used as follows, entering it at the Holladay program.
2nd assumption: We now Rpre, Rpost and Kpost
A) Difference of refraction method

Corrected Kpost = Kpost-0.23*(Rpost-Rpre)

The obtained Kpost-corr value can be used as follows, entering it at the Holladay
program.
3rd assumption: We only now Kpost

A) Rosa method

Corrected refraction with Rosa formula (Rrosa)=R(0.0276*LA+0.3635)


R -337.5/Kpost
LA= Axial longitude
Kpost-corrected Rose = 337.5/Rrosa

a) With the Kpost value that we have, we will obtain the


R value
b) Then, we enter the R and LA values in the formula and
we get the value of Rosa’s corrected refraction
Kpost-corr Rosa = 337.5/Rrosa
c) The Rosa formula only uses the SRK formula (SRK/T if
AL < or SRK II if AL >29.4mm
The obtained value of Kpost-corr will be used as follows, entering it to the
Holladay program.
Annex 14:

PATIENTS PREOPERATIVE INSTRUCTIONS

THREE DAYS BEFORE INTERVENTION


 CILCLAR 20. The patient has to clean the palpebral border and
eyelashes with this towels, two times a day (morning and night)
Please do not wear makeup 4 days before the intervention, do not use parfum or cologne
the day of the surgery.

 AZYDROP 15 mg/g one drop 2 times a day (breakfast and dinner).

The day before the intervention


 DICLOFENACO MONODOSE: One drop 3 times (breakfast, meal and
dinner)
Wait 5 minutes between one and another and from the two different eye drops.

The day of the intervention


 DICLOFENACO MONODOSE the following way :
 1 drop half an hour before coming to the clinic.
 Another drop 10 minutes after.
 A third drop 10 minutes after.

Do not suspend any ocular treatment that you are using, except when your
ophthalmologist tells you other wise

REFRAIN FROM EATING FOR 5 HOURS BEFORE THE INTERVENTION


(EVEN WATER).
IF YOU ARE DIABETIC and the surgery will be performed:
 At morning do not have breakfast nor administrate insulin nor oral
hypoglucemiants.
 At afternoon, have breakfast and administrate the insulin that corresponds or the
antidiabetic that corresponds.
If you are under anticoagulant treatment (such as SIMTROM, ASPIRINA, TIKLID,
or others). If you have any doubt ¡¡¡ask us!!!. You can take the rest of your medication
as normal.
NECESARY TESTS FOR THE SURGERY PERFORMANCE
 IN ADULTS Complete preoperative: analytic, including hemogram, bioquimic,
coagulation, and electrocardiogram.
 THE CHILDREN must bring an updated pediatric report.
 If the preoperative examination is done outside from our center, the
patient must send it as soon as possible, personally or by fax
(965.26.05.30)
 It‘s not possible, the patient will bring it the day of the intervention, as
well as medical reports that he has or the actual treatment that he’s taking.

ESSENTIAL CONDITIONS FOR THE OPERATING THEATER


ENTRANCE:
TO ENTER TO THE OPERATING THEATER THE PATIENT MUST BE
WEARING CONFORTABLE CLOTHES, NO DENTAL PROTHESIS, NO NAIL
POLISH, NO MAKE UP, WITHOUT JEWERLY.
 MUST BE ACCOMPANIED THE DAY OF THE SURGERY.

Annex 15
PATIENT POSTOPERATIVE INSTRUCTIONS

You have just been operated.


With the most modern techniques that will allow you to incorporate immediately to your
usual environment and familiar.
During the first days after surgery, your vision will be cloudy and imprecise, you will
recover it over time
You will notice a touch sensation in the superior eyelid, this will be decreasing over time
If the light discomfort are very important you can use conventional sun glasses.

Discharge instructions.
Even though you are in conditions of leaving the ambulatory surgery unit, when you get
discharge, is important to remember that you still are under effect of one or several
medications used in the anesthesia and you must follow the next instructions:
 Do not drive motorized vehicles for the next 24 hours
 Do not drink alcoholic beverages during the first 24 hours
 You can continue with all of your medication that you were using previously for
other health conditions.
 Do not do important efforts, avoid lifting weight over 10 kgs.

 Avoid rubbing your eyes, especially if your hands are dirty or with handkerchiefs.
Use sterile gauzes
 Apply correctly the prescribed eye drops, avoid touching your eyes.
 Have special attention with falls and hits.
 Use to sleep the plastic protector during the first postoperative week
 Except with the afore mentioned, you can do regular activities, going out,
reading, watching television, if your vision allows it.

IMPORTANT:
In case that you notice:
Decreased of the vision obtained after surgery
 Abundant eyelid crusting
 Sudden and manifest pain in the operated eye days after surgery.
 Sudden and manifest important redness days after surgery
You should contact us immediately by calling the following citation telephone:
(Phone of contact). If it’s Saturday, Sunday or a hollydays, call our 24 HOURS
OPHTHALMOLOGIC EMERGENCIES

 OFTACILOX® 1 drop 4 times a day for 7 days.


 VOLTAREN® 1 drop 3 times a day for 6 weeks.
 MAXIDEX® 1 drop 4 times a day for 10 days.
 PARACETAMOL (Efferalgan) in case of pain or
discomfort.

* Wait for 5 minutes between the eye drops application.

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