Comparison Study of Funduscopic Examination

Using a Smartphone-Based Digital Ophthalmoscope

and the Direct Ophthalmoscope
Amy Ruomei Wu, BA; Samiksha Fouzdar-Jain, MD; Donny W. Suh, MD

ABSTRACT Conclusions: The D-EYE digital ophthalmoscope is a

Purpose: To assess the ease of use of the D-EYE digi-
tal ophthalmoscope (D-EYE Srl, Padova, Italy) in retinal
screening against the conventional direct ophthalmo-
scope. The digital ophthalmoscope used comprised a
smartphone equipped with a D-EYE lens that produces
digital retinal images.
Methods: Twenty-five medical students were given 30
minutes of instruction regarding how to use a direct
ophthalmoscope and D-EYE digital ophthalmoscope
by a pediatric ophthalmologist. Afterwards, they used
two methods to view the fundus under dim light on
two undilated volunteer participants under supervision
of the pediatric ophthalmologist. Each student had to
describe their findings and show the video taken from
the smartphone to the pediatric ophthalmologist. Stu-
dents also completed a survey rating their experience
using each method.
Results: Ninety-two percent of the medical students
preferred the D-EYE digital ophthalmoscope to the di-
rect ophthalmoscope. Students were also able to iden-
tify the optic nerve and macula in a shorter amount of
time and review the images to confirm their findings.
Overall, the medical students showed a strong prefer-
ence for the D-EYE digital ophthalmoscope that was
statistically significant (P < .001).
practical device that could be incorporated into medi-
cal education and clinical practice. Survey results re-
vealed that most students preferred the D-EYE digital
ophthalmoscope due to the recording features and
larger image of the fundus.
[J Pediatr Ophthalmol Strabismus. 2018;55(3):201-
206.]
INTRODUCTION
In the United States and abroad, the use of
smartphones is ubiquitous in everyday life and has
strongly influenced our culture. This revolution in
technology has provided us with utilitarian devices
that are portable, easy to learn and use, and com-
patible with applications (apps) that fill a variety of
niches. These features are what make smartphones
so relevant to health care, although they remain a
resource in medicine that is still vastly untapped.
However, new telemedicine-based apps and accesso-
ries are being developed in the field of ophthalmol-
ogy that allow the user to capture images or videos
and document ocular or fundal pathologies with
their smartphones, such as the D-EYE (D-EYE Srl,
Padova, Italy), iExaminer (Welch Allyn, Skaneateles
Falls, NY), and Paxos (Digisight Technologies, Inc.,

From Creighton University School of Medicine, Omaha, Nebraska (ARW); and the Department of Pediatric Ophthalmology, Children’s Hospital and
Medical Center, Omaha, Nebraska (SF-J, DWS).
Submitted: January 3, 2017; Accepted: September 7, 2017
The authors have no financial or proprietary interest in the materials presented herein.
The authors thank Jared Smith from the Creighton University School of Medicine Class of 2019, Patrick Grogan and Daniel Agraz from the University of
Nebraska Medical Center Classes of 2018 and 2017, respectively, and Alex Suh for their help in conducting the experiment; Robin High and Collin Macdonald
for their help with the data analysis; Linda Morgan for reviewing the paper; and Children’s Hospital and Medical Center for providing the venue for the study.
Correspondence: Amy Ruomei Wu, BA, Creighton University School of Medicine, 2500 California Plaza, Omaha, NE 68178. E-mail: Ruomeiwu@
creighton.edu
doi:10.3928/01913913-20180220-01

Journal of Pediatric Ophthalmology & Strabismus • Vol. 55, No. 3, 2018 201

Figure 1. The D-EYE digital ophthalmoscope (D-EYE Srl, Padova,
Italy) is a fundus camera that attaches to a smartphone to allow
viewing of the retina, with the capability of taking digital still im-
ages or videos during the funduscopic examination. The iPhone is
manufactured by Apple, Inc., Cupertino, CA.
San Francisco, CA) digital ophthalmoscopes. Not
only does this improve the ease of retinal screening
for physicians and patients alike, but it also enables
greater collaboration between primary and specialty
medicine. Additionally, these recording features can
be used to monitor patients over time for changes or
development of ocular pathologies. They may also
improve ease of screening in less compliant popula-
tions, such as pediatric patients. With many such
devices gaining popularity, the relative costs have
decreased, which provides the potential to enhance
access to vision care in underserved areas.1
Currently, there are various mobile digital reti-
nal screening devices available, such as the iExam-
iner and Paxos digital ophthalmoscopes. However,
the most widely used methods of retinal screening
include the PanOptic Ophthalmoscope (Welch Al-
lyn) and the direct and indirect ophthalmoscope,
in addition to more sophisticated methods such
as digital retinal screening and optical coherence
tomography. However, the latter methods may be
cost prohibitive and lack portability. Also, sharing
information among physicians in various medical
institutions can be difficult due to compliance with
the Health Insurance Portability and Accountabil-
ity Act (HIPAA). Alternatively, the former methods
require more time and practice to master because
the devices and techniques used are highly special-
202
ized. This often leads to general practitioners feeling
unequipped and unprepared to properly detect and
diagnose retinal pathology in their patients.
The D-EYE digital ophthalmoscope (Figure 1)
is a device that can help fill the void in accessible and
intuitive retinal screening technology. The device is
a fundus camera that attaches to smartphones and is
used in conjunction with a HIPAA-compliant app.
The device is approved by the U.S. Food and Drug
Administration and costs $399.95. It is used simi-
larly to a direct ophthalmoscope and can capture a
digital still image or video of the retina on the smart-
phone screen.
The examination can be performed on both an
undilated and dilated pupil. When the pupil is di-
lated, the device has a field of view of 20° in a single
fundus image at a distance of 1 cm from the patient’s
eye. When examining an undilated patient, the field
of view is approximately 5° to 8°. The anterior lens
works similarly to a telescope and the posterior lens
uses a beam splitter to redirect the light that would
commonly cause corneal glare when using a tradi-
tional ophthalmoscope.2 The device can be used to
screen and record a variety of pathologies, such as
glaucoma, age-related macular degeneration, dia-
betic retinopathy, blood vessel abnormalities, hem-
orrhages, optic nerve disorders, neuritis, and cotton
wool spots.3 It can also be used for pediatric condi-
tions such as retinoblastoma, optic nerve head and
retinal colobomas, congenital cataract, and abusive
head trauma.4 Although the D-EYE digital ophthal-
moscope uses both hands, pediatric patients are more
familiar with a smartphone than any other ophthal-
mic instrument and are more likely to be compliant
with a D-EYE digital ophthalmoscope examination.
Using two participants with undilated pupils as hu-
man models, we investigated the ease of use of the
D-EYE digital ophthalmoscope in retinal screening
against the conventional direct ophthalmoscope.
PATIENTS AND METHODS
In this study, 25 medical students examined
the fundi of two undilated participants using the
traditional direct ophthalmoscope and the D-EYE
digital ophthalmoscope. Nine students were from
the University of Nebraska Medical Center, Oma-
ha, Nebraska, and 16 were from the Creighton
University School of Medicine, Omaha, Nebraska.
Medical students were selected as test participants
based on their availability and cooperativity. Par-
Copyright © SLACK Incorporated

Figure 2. A student demonstrating use of the D-EYE digital oph-
thalmoscope (D-EYE Srl, Padova, Italy) to view the retina of an un-
dilated participant.
ticipants were notified of the study through a re-
cruitment e-mail and self-selected to participate.
Their age range was 18 to 30 years. This study was
exempt from institutional review board approval
based on its design as a quality improvement proj-
ect that met the following criteria: the primary
intent of the project was to improve the quality
of patient care or efficiency of a health care op-
eration, the project design used established qual-
ity improvement methods, and the project did not
impose any increased physical or psychological risk
or burden on patients or other participants.
The D-EYE digital ophthalmoscope and direct
ophthalmoscope examinations were performed in a
dimly lit room to maximize pupil dilation (Figures
2-3). To assess ease of use of the D-EYE digital oph-
thalmoscope on patients, two undilated participants
of the total pool of participants were selected to act
as study models. They alternated being the study
model every few minutes to minimize discomfort
from eye strain, so only one participant was being
examined by the students at any given time.
We used the D-EYE digital ophthalmoscope
made for the iPhone 6 (Apple, Inc., Cupertino, CA)
in conjunction with the D-EYE Care app (D-EYE
Srl). The app offers two types of examinations: mul-
tishot and video. It also has separate settings and au-
tofocus techniques for viewing dilated and undilated
eyes. If viewing an undilated eye, the refractive error
Journal of Pediatric Ophthalmology & Strabismus • Vol. 55, No. 3, 2018
Figure 3. A student demonstrating use of the direct ophthalmo-
scope to view the retina of an undilated participant.
must be specified. All students used the D-EYE video
setting for extended retinal viewing on an undilated
emmetropic eye, which offers a field of view of 5° to
8°. To configure the autofocus mechanism for an un-
dilated eye, the camera was focused on a target at an
infinite distance (> 3 m) in a brightly lit area. The
autofocus was allowed to settle to provide the sharp-
est image, and then the settings were locked to main-
tain a focused image on the smartphone screen. The
examiner then maneuvered the iPhone 6 camera to
locate the red reflex, which is viewed on the smart-
phone screen. Once located, the iPhone 6 was moved
closer to the eye at a slight upward angle and 15° tem-
porally until the camera lens was 1 cm from the pupil
and the student instructed the participant to fixate on
an object 10 meters away. The D-EYE camera was
moved around in a slow circular motion in front of
the eye until the entire fundus, including the optic
nerve, was visualized (Figure 4). For simplicity, this
method will be referred to as the “D-EYE method”
for the remainder of the study.5
Students also used a direct ophthalmoscope to
visualize the retina of the study participants. The fo-
cus was first adjusted by the student researchers to
a refractive error of zero. The examiner, positioned
at eye level, lifted the study participant’s upper eye-
lid with the hand not holding the ophthalmoscope
for a wider field of examination. The examiner then
placed the ophthalmoscope in front of the partici-
pant’s eye from a distance of 6 to 12 inches to lo-
cate the red reflex. Once located, the examiner ap-
proached the participant until approximately 1 to 2
inches away from the participant’s eye. To view the
entire fundus, the examiner would simply pivot the
ophthalmoscope to visualize each of the quadrants.
203

Figure 4. An example of the D-EYE Care application (D-EYE Srl, Pa-
dova, Italy) retinal still image showing a centered optic nerve.
After students completed the 30-minute train-
ing, they used the direct and D-EYE digital oph-
thalmoscopes to view the fundi of the participants.
Each student was given 2 minutes to use both de-
vices on one participant, visualize the optic nerve,
describe his or her findings, and show the video
taken from the smartphone to the pediatric oph-
thalmologist. The students were also asked to fill
out a 5-question survey about their experiences
learning to use the two methods. The survey was
as follows:
1. Difficulty of direct ophthalmoscope. Please rate
on a scale of 1 to 5 (1 = most difficult and 5 =
least difficult).
2. Difficulty of D-EYE ophthalmoscope. Please
rate on a scale of 1 to 5 (1 = most difficult and 5
= least difficult).
3. Which method do you prefer and why?
4. Comments about the experiment.
5. Comments about the D-EYE ophthalmoscope.
204
Finally, two statisticians from the University of Ne-
braska Medical Center were recruited for data analysis.
RESULTS
Based on ratings on a 5-point scale from the sur-
vey, 20 of the 25 students concluded that the D-EYE
digital ophthalmoscope was easier to use than the di-
rect ophthalmoscope. However, results showed that
the overall difference in rating was not statistically
significant between the ophthalmoscopes, although
several students rated the D-EYE digital ophthal-
moscope much higher (eg, one student gave a rating
of 1 and 5 to the direct and D-EYE digital ophthal-
moscopes, respectively). The average rating on the
5-point scale was 3.00 for the direct ophthalmoscope
and 4.08 for the D-EYE digital ophthalmoscope.
No student rated both devices with the lowest score.
Of the 5 students who rated the D-EYE digital oph-
thalmoscope as more difficult to use than the direct
ophthalmoscope, 3 still ranked a preference for the
D-EYE digital ophthalmoscope.
The Spearman correlation had a value of 0.0785,
with an exact predictive value of 0.70. This indicates
that there was no relationship between the two sets
of rankings. A P value of independence for both de-
vices was computed with a test specifically for small
sample sizes. A 2 × 2 table was generated and, in both
cases, the P value was not significant for either device.
The Pearson chi-square test value was 0.63. Also, sub-
jectively, most students reported that they were able
to identify the optic nerve and macula in a shorter
amount of time with the D-EYE digital ophthalmo-
scope; only 2 students were able to perform the ex-
amination faster with the direct ophthalmoscope.
Overall, 92% (23 of 25) of students who par-
ticipated in the study preferred the D-EYE digital
ophthalmoscope as opposed to the direct ophthalmo-
scope. The Pearson chi-square test had an exact P val-
ue of 1.00 when comparing students from Creighton
University School of Medicine to those from the Uni-
versity of Nebraska Medical Center, which indicates
that university affiliation did not affect device pref-
erence. Overall, students from both medical schools
showed a strong, statistically significant preference for
the D-EYE digital ophthalmoscope (P < .001).
DISCUSSION
Based on the results of our study, we concluded
that the D-EYE digital ophthalmoscope is easy to
Copyright © SLACK Incorporated
use and favored by most of the participating medi-
cal students. We propose that this device could be
incorporated into medical student education and
clinical practice.
The survey yielded valuable feedback regard-
ing students’ subjective experiences using both sys-
tems. Many noted that the D-EYE digital ophthal-
moscope provided a larger field of view at a further
distance away from the patient, making it easier
to locate the optic disc and visualize blood vessels.
This made it more comfortable for both the exam-
iner and participants. This may provide a safer dis-
tance from the patient for the examiner, especially
in a hospital setting. Students also enjoyed the
recording feature of the D-EYE digital ophthal-
moscope, commenting that this would facilitate
improved communication with both patients and
physicians of other medical specialties. Many stu-
dents perceived that the D-EYE method was faster
than the direct ophthalmoscope, although the time
taken to perform each method was not measured.
Of the students who found the direct ophthalmo-
scope to be faster, both had previous experience
with the device. Some students had reservations
about the D-EYE digital ophthalmoscope because
they found angling the device to visualize the fun-
dus to be slightly challenging and that it took a few
more seconds for the D-EYE digital ophthalmo-
scope to focus. Some students noted that the image
was grainy and had a slightly purple glare. Similar
to the direct ophthalmoscope, there is still a learn-
ing curve with the D-EYE digital ophthalmoscope.
The survey results also showed that 5 students
rated the D-EYE digital ophthalmoscope as more
difficult to use than the direct ophthalmoscope.
Of that group, 3 students still preferred the D-EYE
digital ophthalmoscope. These students noted that
angling the D-EYE digital ophthalmoscope to view
the peripheral retina was difficult, requiring some
time, practice, and dexterity. However, they ulti-
mately preferred the D-EYE digital ophthalmoscope
because it produced a larger image of the fundus, in
addition to the recording features.
Our study has several limitations. There was a
lack of randomization in assigning which method
students used first because students were allowed to
choose which device they tested first. Most students
started with the direct ophthalmoscope due to prior
experience using the device. In addition, we only
had two participants to be examined. Questions
Journal of Pediatric Ophthalmology & Strabismus • Vol. 55, No. 3, 2018
regarding the ability of students to retain the skills
for the D-EYE method may arise because this study
took place at one time point. However, as with any
skill, practice is required to gain competency. Our
study aimed to compare the ease of use between the
two methods and could only compare what students
were seeing between the two imaging modalities
based on their description of their findings with the
direct ophthalmoscope because there was no image
capture option. Although we assessed the examiner’s
preference, studies to evaluate patient preference
would be helpful, and are currently being conducted
at the University of Nebraska Medical Center and
Creighton University School of Medicine. Stud-
ies to evaluate physician preference for the D-EYE
digital ophthalmoscope would also be valuable be-
cause they would be more experienced with existing
screening tools (ie, the direct ophthalmoscope) than
medical students, who may prefer smartphone de-
vices because of their relative familiarity.
Several other studies have been conducted with
the D-EYE digital ophthalmoscope that concentrate
on comparing the clinical accuracy of D-EYE smart-
phone ophthalmoscopy against traditional methods
of screening in identifying ocular pathologies.6,7 A
2016 study by Russo et al.6 studied the agreement
between the D-EYE digital ophthalmoscope and
slit-lamp indirect biomicroscopy when used for reti-
nal screenings in patients with ocular hypertension
or primary open angle glaucoma. Results indicated
that the two methods showed good agreement when
evaluating the vertical cup–disc ratios.6
Muiesan et al.7 conducted a study that com-
pared the feasibility of performing ocular fundus
examinations with the D-EYE digital versus direct
ophthalmoscopes in an emergency department set-
ting to better capture the diagnosis of hypertensive
emergencies. Forty-one consecutive patients pre-
senting to the emergency department with an acute
increase in blood pressure (ie, systolic blood pressure
> 180 mm Hg and/or diastolic blood pressure > 100
mm Hg) had a mydriatic funduscopic examination
by an emergency physician using both a tradition-
al direct and D-EYE digital ophthalmoscope.7 Of
these, no relevant abnormalities of the funduscopic
examination were detected by the emergency physi-
cian when using the direct ophthalmoscope.7 How-
ever, abnormal examination findings were detected
by the use of the D-EYE digital ophthalmoscope
in 17 and 19 patients by the emergency physician
205
and ophthalmologist, respectively.7 This study con-
cluded that the D-EYE digital ophthalmoscope with
its recording capability is better at detecting abnor-
malities on funduscopic examination than the direct
ophthalmoscope.7
These studies demonstrate the D-EYE digital
ophthalmoscope’s effectiveness in providing a fun-
duscopic examination that is comparable to the
results of a direct ophthalmoscope, particularly for
non-ophthalmologists. Our study indicates that the
D-EYE digital ophthalmoscope is a useful device
that is intuitive to learn and use, in addition to be-
ing portable and cost effective, which may make it
an attractive device for younger clinicians, students,
and residents who are likely already more familiar
with smartphone use. Overall, the study supports
that incorporating the use of the D-EYE digital
ophthalmoscope has positive implications in clinical
practice both during the process of medical training
and in patient outcomes due to improved diagnoses.
Student feedback was overwhelmingly positive
for the D-EYE digital ophthalmoscope. The record-
ing feature and ease of use were two of the most fre-
quently cited advantages of this device. Given these
features, the D-EYE digital ophthalmoscope seems
206
to be an innovative and appropriate tool for docu-
menting and examining the fundus as compared to
a direct ophthalmoscope.
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