A Feasibility Study of Retinal Screening Using the RetinaVue 100 Hand- Held (Non-mydriatic) Camera in Outpatient Dialysis Centers
Phase: NA
Conditions: Kidney Failure, Chronic, Eye Diseases, Diabetic Retinopathy
Sponsor: University of North Carolina, Chapel Hill

 
 
 
A Feasibility Study of Retinal Screening Using the RetinaVue 100 Hand-Held  
(non-mydriatic) Camera in Outpatient Dialysis Centers 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT02823600 
September 2016 

RetinaVue 100 Feasibility Study 
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A Feasibility Study of Retinal Screening Using the RetinaVue 100 Hand-Held (non-mydriatic) Camera in 
Outpatient Dialysis Centers 
 
Short Title: Retinal Screening with RetinaVue 100 in Outpatient Dialysis Centers 
Sponsor: The University of North Carolina at Chapel Hill 
Protocol Date: 04/26/2016 
Amendment 1 Date: 07/13/2016 
Amendment 2 Date: 09/16/2016 
 
 
 
 
 
 
 
 
 
 
The University of North Carolina at Chapel Hill  
Chapel Hill, NC 27599  
United States  
Study Principal Investigator Seema Garg, MD, PhD 
5132 Bioinformatics Building  
Chapel Hill, NC 27599 
Phone (919) 966-5296  
email: sgarg@med.unc.edu 
 
 
 
 
 

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TABLE OF CONTENTS 
Table of Contents ............................................................................................................. 3 
Abbreviations and Definitions of Terms .............................................................................. 4 
Protocol Synopsis ............................................................................................................. 5 
1 
BACKGROUND  AND RATIONALE .................................................................................................................... 6 
2 
STUDY OBJECTIVES ......................................................................................................................................... 6 
3 
INVESTIGATIONAL PLAN ................................................................................................................................. 7 
4 
STUDY PROCEDURES....................................................................................................................................... 7 
5 
STUDY EVALUATIONS AND MEASUREMENTS ................................................................................................. 8 
6 
STATISTICAL CONSIDERATIONS....................................................................................................................... 8 
7 
SAFETY MANAGEMENT................................................................................................................................... 9 
8  DATA COLLECTION AND MANAGEMENT ........................................................................................................... 9 
9 
RECRUITMENT STRATEGY ............................................................................................................................. 10 
10 CONSENT PROCESS ....................................................................................................................................... 10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
Abbreviation 
Definition 
ESRD 
End-stage renal disease  
CSME 
Clinically significant macular edema 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SYNOPSIS 
Study Title 
A Feasibility Study of Retinal Screening Using the RetinaVue 
100 Hand-Held (non-mydriatic) Camera in Outpatient Dialysis 
Centers 
 
Funder 
WelchAllyn 
Clinical Phase 
Feasibility  
Study Rationale 
There are no studies evaluating (diabetic or non-diabetic) 
retinopathy in the renal dialysis patient population (~300,000 
Americans). Approximately 50% of this population has End-stage 
Renal Disease (ESRD) due to diabetes. Dialysis patients are among 
the most debilitated patients, and thus, have even more barriers to 
receiving their recommended annual retinal evaluation.   The advent 
of the RetinaVue hand-held retinal camera holds great promise in 
this population, as dialysis patients access medical care 3 times a 
week, for several hours at a time at their dialysis clinic.    
Study Objective(s) 
Primary  
To evaluate the usability of the FDA-approved RetinaVue Hand-
Held 100 Camera in a population with multiple chronic conditions  
 
Secondary 
• 
To evaluate pre-and-post-screening rates in the diabetic dialysis 
population.  
• 
To determine the proportion of overall retinopathy in a dialysis 
population  
• 
To evaluate participant satisfaction of screening utilizing the 
FDA-approved RetinaVue 100 hand-held camera 
Study Design 
This is a feasibility study.  
Subject Population 
key criteria for 
Inclusion and Exclusion: 
Inclusion Criteria 
• The subject must currently be seeking treatment for end-
stage renal disease (ESRD) at one of the specified dialysis 
clinics. 
• The subject must be ≥ 18 years of age. 
Exclusion Criteria 
• The subject is <18 years of age.  
Number Of Subjects  
Up to 250 participants  
Study Duration 
Each subject’s participation may last up to 1 year.  
The entire study is expected to last about 1 year.  
Study Phases 
Screening 
Intervention 
Follow-Up   
 (1) Screening for eligibility and obtaining consent, (2) Obtaining 
retinal images, completion of satisfaction survey, and medical 
record abstraction (3) For those participants recommended for 
referral, they will be given the opportunity to follow up with the 
remote provider.   
Statistical And Analytic 
Plan 
To assess usability of camera utilization, the primary objective, the 
proportion of inadequate images will be calculated.   

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1 
BACKGROUND AND RATIONALE 
1.1 
Introduction 
 
There are no studies evaluating (diabetic or non-diabetic) retinopathy in the renal dialysis patient 
 
population (~300,000 Americans).  Approximately 50% of this population has End-stage Renal
 
Disease (ESRD) due to diabetes.  Dialysis patients are among the most debilitated patients, and thus, 
 
have even more barriers to receiving their recommended annual retinal evaluation. The advent of the 
 
RetinaVue hand-held retinal camera holds great promise in this population, as dialysis patients access 
 
medical care 3 times a week,  for several hours at a time at their dialysis clinic.    
1.2 
Non-Clinical and Clinical Study Findings 
Potential Benefits:   
The potential benefits to subjects from being in this study may include receiving a screening of their 
eyes, a diagnosis, and potential follow up that they may not have received unless the were in the study. 
 
Risk /Benefit Assessment:  
A possible side effect expected would be temporary discomfort in the eye/s due to the camera flash. This 
is seen infrequently in the clinical setting and should not last more than 2-3 minutes. 
 
As part of the eye exam, drops may be put in the eyes to dilate the pupils.  The drops may blur vision 
and make the subject sensitive to light.  The drops will wear off over several hours.  There is a small risk 
of an allergic reaction to the drops.  There is also a small risk that the drops could cause the eye pressure 
to rise.  If this happens, it will be treated, but there is a small risk of losing vision from the pressure 
rise.  Due to the blurring effect on vision and possible light sensitivity, we will recommend that the 
subject not drive until the blurring effects of the drops have worn off.  If necessary, the subject should 
have someone with them who can drive for them after the exam. 
 
There may be uncommon or previously unknown risks.  
 
2 
STUDY OBJECTIVE  
Primary Objective:   
• To evaluate the usability of the FDA-approved RetinaVue Hand-Held 100 Camera in a population with 
multiple chronic conditions  
 
Secondary Objective  
• To determine rates of overall retinopathy in a dialysis population  
• To evaluate participant satisfaction of screening utilizing the FDA-approved RetinaVue 100 hand-held 
camera 
 
 
 
 
 

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3 
INVESTIGATIONAL PLAN  
3.1 
Study Design 
 
This is a feasibility study to evaluate the usability of the FDA-approved RetinaVue 100 and contribute 
 
to knowledge  about integrating teleheath into medical services.  
3.2 
Study Duration, Enrollment and Number of Subjects 
 
The study team anticipates the study duration to be about 1 year.  
 
This study will recruit participants from four UNC outpatient dialysis clinics in the following 
 
locations: Carrboro, Siler City, Pittsboro, and Mebane, North Carolina. 
 
The study proposes enrolling up to 250 subjects across all four study sites.  
3.3 
Study Population 
Inclusion Criteria 
• The subject must currently be seeking treatment for end-stage renal disease (ESRD) at one of the 
specified dialysis clinics. 
• The subject must be ≥ 18 years of age. 
 
Exclusion Criteria 
• The subject is <18 years of age.  
 
4 
STUDY PROCEDURES (what will be done) 
• Determine last documented retinal examination (electronic medical record) 
• Determine cause of End-stage Renal Disease (ESRD) and vintage, I.e. how long patient has been on 
dialysis (paper chart)   
• Determine patient demographics (electronic medical record) 
•  
DOS, DOB (age) 
•  
Gender, race 
•  
Medical history (coronary artery disease, stroke, hypertension, if diabetes -duration) 
•  
Medical labs (HbA1c, cholesterol, blood pressure) 
•  
Smoking history 
•  
Social determinants of health (education level, insurance status, etc). 
• Check bilateral visual acuity with near card. 
• Obtain bilateral retinal photographs with or without dilation. 
• Complete the Usability survey. 
• Complete the Participant Satisfaction survey. 
• Upload patient images and metadata.  
• Through the study PI, a board-certified ophthalmologist, interpret patient retinal images and return 
of diagnosis and management plan to dialysis unit including a wellness report to be given to 
individual subjects. 
• Analyze data with biostatistician consultant 
• Timeline. Quarter 1 (May –August 2016): Retinal image and metadata acquisition, clinic 1 and 2; 
Quarter 2 (September 2016-November 2016): retinal image and metadata acquisition clinic 3 and 4; 
Quarter 3 (December 2016-February 2017): data analysis; Quarter 4 (March 2017-May 2017): 
manuscript and presentation preparations. 
• Subject results will be entered into the medical record. If something of note is found in a subject's 

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retinal scan, then staff at the dialysis clinic will provide follow up for any abnormalities found as 
part of clinical care. 
 
5 
STUDY EVALUATIONS AND MEASUREMENTS   
The following variables will be abstracted from medical records:  
• Last documented retinal examination, cause of End-stage Renal Disease (ESRD) and vintage, I.e. how 
long patient has been on dialysis, DOS, DOB (age), gender, race, medical history (coronary artery 
disease, stroke, hypertension, if diabetes -duration), medical labs (HbA1c, cholesterol, blood pressure), 
smoking history, social determinants of health (education level, insurance status, etc). 
Obtaining retinal images 
• Nonmydriatic fundus images of both eyes were obtained from participants using the WelchAllyn 
RetinaVue™ 100 Imager.  For those subjects with pupils smaller than 3 mm in either eye, a low dose 
dilation drop of 0.5% tropicamide will be administered to enlarge the pupil and assist in image capture. 
The images will be electronically sent via a HIPAA compliant portal to an offsite, board-certified 
ophthalmologist for remote interpretation.  Following interpretation, a report will be generated that 
details any clinical findings and referral recommendations, which will then be distributed to individual 
subjects and uploaded to their electronic medical record.  For those participants recommended for 
referral, they will be given the opportunity to follow up with the remote provider.   
Participant satisfaction survey  
• Participants will be asked to complete a brief participant satisfaction survey, which asks questions 
regarding their satisfaction with their exam experience.  The survey utilizes a five-point Likert scale 
with responses ranging from strongly agree (1) to strongly disagree (5). The survey also allows for 
participants to provide qualitative observations about their experience. The survey asks about 
satisfaction of time to complete exam, comfort during the exam, comfort after the exam, first eye 
recovery after the camera flash, second eye recovery after the camera flash, and satisfaction with overall 
experience.  
 
6   
STATISTICAL CONSIDERATION    
6.1 Statistical Methods 
Descriptive analyses will be used to assess demographic and medical history variables, camera usability, 
overall retinopathy, and participant satisfaction data. To assess usability of camera utilization, the 
proportion of inadequate images will be calculated.  For participant satisfaction data, a response rate will 
be calculated followed by an overall mean score and standard deviation, and proportions for each of the 
six survey components. To assess overall retinopathy, a three-category outcome variable for retinopathy 
and referral at the individual level will be determined: (1) No retinopathy, (2) retinopathy without 
referral, and (3) retinopathy with referral.  The following definitions will be determined (results for pairs 
of eyes will take into account that there may be some unreadable images): If the diagnosis in both eyes 
is no retinopathy then the individual has no retinopathy; otherwise, if either eye is considered severe, has 
proliferative diabetic retinopathy, clinically significant macular edema (CSME), or an inadequate image, 
the individual will be put into the retinopathy with referral category; likewise, if either eye is 

RetinaVue 100 Feasibility Study 
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mild/minimal or moderate retinopathy without CSME, then the individual will be placed into the 
retinopathy non-referral category. 
6.2 Sample Size and Power 
The study aims to recruit and collect data from all individuals currently receiving treatment at the 
specified dialysis clinics. As such, the proposed sample (N=250) reflects the number of patients actively 
seeking treatment at those sites. Furthermore, this is a feasibility study and therefore 250 subjects is 
sufficient for the study team to determine the usability of the camera and to determine the prevalence of 
retinal disease in the dialysis population. In such a study, a power calculation is not indicated. 
 
7  
SAFETY MANAGEMENT 
This study presents no more than minimal risk to participants and as such, the study team does not 
anticipate any obvious safety concerns. However, the study team and/or a representative for 
WelchAllyn, Inc. will periodically monitor the data for the study duration. 
 
As defined by UNC’s IRB, unanticipated problems involving risks to study subjects refers to any 
incident, experience, or outcome that: 
Is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and informed 
consent document; and (b) the characteristics of the subject population being studied; Is related or 
possibly related to a subject’s participation in the research; and suggests that the research places subjects 
or others at a greater risk of harm (including physical, psychological, economic, or social harm) related 
to the research than was previously known or recognized. 
 
Any events that meet the criteria for “Unanticipated Problems,” as defined by UNC’s IRB will be 
reported by the study staff using the IRB’s web-based reporting system. 
 
Though the likelihood of adverse events and other UPs for this trial is low, the study team plans to 
review data on a weekly or biweekly basis in order to determine whether there are safety concerns or 
other unexpected problems occurring. In the event that safety concerns or other problems arise, the study 
team will meet to create a plan to remedy any issues. 
 
8  
DATA COLLECTION AND MANAGMENT  
Obtained study data will be recorded in an Excel spreadsheet which will be made available to study 
staff. Subsequent data management will be the responsibility of the study staff for quality control 
assurance and integrity of data and will occur concurrently with data collection. In addition, a 
representative of the funding source will occasionally monitor the data. 
 
The research study staff will use patient records, both paper and electronic format, and will conduct this 
research according to the UNC established conditions for the collection of medical and personal 
information as part of doing this research study. All information obtained in this study that can be 
identified with subject name will remain confidential as far as possible. No names will be revealed in 
any reports or publications resulting from this study without consent of the subject. The members of the 
research team, monitors, and any country, state or federal regulatory agencies or the Institutional Review 
Board may access the data. 
 
When the study has been terminated with the UNC IRB, hardcopy files which may include identifiable 
data will be stored onsite within the Research Manager's office for a period of 4 years or until has been 

RetinaVue 100 Feasibility Study 
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requested to be destroyed by the PI, whichever comes first. All protocol and/or identifiable data, when it 
can be destroyed, will be placed in a secured, university issued, confidential recycling bin for shredding. 
 
9  
RECRUITMENT STRATEGY 
Subjects will be identified at dialysis centers as those subjects currently seeking treatment. All subjects 
listed as being a patient of the dialysis unit will be approached by a member of the study team while in 
clinic.  
 
10  CONSENT PROCESS 
Before recruitment and enrollment onto this study, potential subjects will be approached about the study 
by study personnel and given the informed consent document for review. A study team member will 
review the consent document with the subject and/or their representative allowing ample time for 
questions, answers and clarifications. After a thorough review, with all parties satisfied about the 
research trial, subjects wishing to participate will be asked to sign and date the Informed Consent 
document. Once the subject signs and dates the informed consent along with the individual obtaining 
consent, the appropriate copies will be distributed to the study files, and a copy given to the subject for 
their own records.