Feasibility Study of Retinal Screening Using the RetinaVue 100 Camera in Outpatient Dialysis Centers

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT02823600
• Collaborator: Welch Allyn (Industry)
• Enrollment: 68
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

The purpose of this research study is to look at retinal abnormalities in outpatient renal dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic; Eye Diseases; Diabetic Retinopathy	Device: RetinaVue 100 camera	N/A

Detailed Description

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 Retinal 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 Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: A Feasibility Study of Retinal Screening Using the RetinaVue 100 Hand- Held (Non-mydriatic) Camera in Outpatient Dialysis Centers
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: RetinaVue 100 camera Participants will have a retinal screening completed by study staff using the FDA-approved RetinaVue 100 hand-held camera	Device: RetinaVue 100 camera; Images of the subject's eye will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit.

Outcome Measures

Primary Outcome Measures

1. Usability of the RetinaVue Hand-Held 100 Camera [baseline visit]

   Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.

Secondary Outcome Measures

1. Overall Retinopathy in a Dialysis Population [Post retinal eye exam]

   Number of participants found to have retinopathy in a dialysis population

2. Participant Satisfaction [Post retinal eye exam]

   Participant satisfaction survey data to be collected following the completion of retinal eye exam. Participants will be assessed on participant satisfaction measures such as comfort of experience, recovery time, and time invested in undergoing procedure vs. traditional retinal exam methods. The survey utilized a five-point Likert scale with the following responses: (1) strongly agree, (2) agree, (3) neutral, (4) disagree, (5) strongly disagree. The outcome measure is reported percentages for each of the six survey components.

3. Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population [Baseline and post retinal eye exam]

   Changes in eye exam rates of the diabetic subset of total population from baseline (i.e. study entry) and post-enrollment in study. Baseline data were to be obtained from the UNC electronic medical record (EMR) as the number of participants with eye exams within the past year and post data would consist of the number of participants completing a study exam.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

• No exclusions will be made on the basis of gender, ethnicity, or race.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC Ophthalmology	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• Welch Allyn

Investigators

• Principal Investigator: Seema Garg, MD, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 16, 2016

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02823600
• Other Study ID Numbers: 16-1116
• First Posted: Jul 6, 2016
• Last Update Posted: Jul 20, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of North Carolina, Chapel Hill: retinal screening; outpatient dialysis
• Additional relevant MeSH terms: Diabetic Retinopathy; Eye Diseases; Renal Insufficiency; Kidney Failure, Chronic

Study Results

Participant Flow

Arm/Group Title	RetinaVue 100 Camera
Arm/Group Description	Participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera RetinaVue 100 camera: Images of the subject's retina will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit.
Period Title: Overall Study
STARTED	68
COMPLETED	68
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	RetinaVue 100 Camera
Arm/Group Description	All participants will have a retinal eye exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera
Overall Participants	68
Age, Customized (years) [Mean (Standard Deviation) ]
No retinopathy	54.7 (18.1)
Retinopathy without referral	60.0 (6.6)
Retinopathy with referral	57.1 (11.6)
Sex/Gender, Customized (Count of Participants)
Female : No retinopathy	17 25%
Female : Retinopathy without referral	6 8.8%
Female : Retinopathy with referral	6 8.8%
Male : No retinopathy	16 23.5%
Male : Retinopathy without referral	5 7.4%
Male : Retinopathy with referral	18 26.5%
Race/Ethnicity, Customized (Count of Participants)
African American: No retinopathy	14 20.6%
African American: Retinopathy without referral	6 8.8%
African American: Retinopathy with referral	11 16.2%
Caucasian: No retinopathy	11 16.2%
Caucasian: Retinopathy without referral	3 4.4%
Caucasian: Retinopathy with referral	8 11.8%
Hispanic: No retinopathy	8 11.8%
Hispanic: Retinopathy without referral	2 2.9%
Hispanic: Retinopathy with referral	4 5.9%
Data Missing	1 1.5%
End-Stage Renal Disease Etiology (Count of Participants)
Diabetes: No retinopathy	7 10.3%
Diabetes: Retinopathy without referral	8 11.8%
Diabetes: Retinopathy with referral	13 19.1%
Hypertension: No retinopathy	12 17.6%
Hypertension: Retinopathy without referral	1 1.5%
Hypertension: Retinopathy with referral	7 10.3%
Other: No retinopathy	13 19.1%
Other: Retinopathy without referral	2 2.9%
Other: Retinopathy with referral	4 5.9%
Data Missing	7 10.3%
Diabetic dialysis population (Count of Participants)
Diabetes: Yes	37 54.4%
Diabetes: No	31 45.6%

Outcome Measures

1. Primary Outcome

Title	Usability of the RetinaVue Hand-Held 100 Camera
Description	Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.
Time Frame	baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Images
Arm/Group Description	This group is the total number of images, 136, captured from the study population.
Measure Participants	68
Measure Retinal Images	136
Inadequate Images	20
Adequate Images	116

2. Secondary Outcome

Title	Overall Retinopathy in a Dialysis Population
Description	Number of participants found to have retinopathy in a dialysis population
Time Frame	Post retinal eye exam

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RetinaVue 100 Camera
Arm/Group Description	All participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera
Measure Participants	68
No retinopathy	33 48.5%
Retinopathy	35 51.5%

3. Secondary Outcome

Title	Participant Satisfaction
Description	Participant satisfaction survey data to be collected following the completion of retinal eye exam. Participants will be assessed on participant satisfaction measures such as comfort of experience, recovery time, and time invested in undergoing procedure vs. traditional retinal exam methods. The survey utilized a five-point Likert scale with the following responses: (1) strongly agree, (2) agree, (3) neutral, (4) disagree, (5) strongly disagree. The outcome measure is reported percentages for each of the six survey components.
Time Frame	Post retinal eye exam

Outcome Measure Data

Analysis Population Description

This analysis is based on responses from the 39 that completed the survey.

Arm/Group Title	RetinaVue 100 Camera
Arm/Group Description	Participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera RetinaVue 100 camera: Images of the subject's retina will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit.
Measure Participants	39
Satisfied time complete eye exam:Strongly agree	61.5 90.4%
Satisfied time complete eye exam : Agree	28.2 41.5%
Satisfied time complete eye exam : Neutral	10.3 15.1%
Satisfied time complete eye exam:Disagree	0 0%
Satisfied time complete eye exam:Strongly Disagree	0 0%
Comfort during eye exam : Strongly agree	75.4 110.9%
Comfort during eye exam : Agree	24.6 36.2%
Comfort during eye exam : Neutral	0 0%
Comfort during eye exam : Disagree	0 0%
Comfort during eye exam : Strongly Disagree	0 0%
Comfort after eye exam : Strongly agree	82.0 120.6%
Comfort after eye exam : Agree	18.0 26.5%
Comfort after eye exam : Neutral	0 0%
Comfort after eye exam : Disagree	0 0%
Comfort after eye exam : Strongly Disagree	0 0%
1st eye quick recovery:Strongly agree	53.9 79.3%
1st eye quick recovery:Agree	41.0 60.3%
1st eye quick recovery:Neutral	5.1 7.5%
1st eye quick recovery:Disagree	0 0%
1st eye quick recovery:Strongly Disagree	0 0%
2nd eye quick recovery:Strongly agree	59.0 86.8%
2nd eye quick recovery:Agree	35.9 52.8%
2nd eye quick recovery:Neutral	5.1 7.5%
2nd eye quick recovery :Disagree	0 0%
2nd eye quick recovery:Strongly Disagree	0 0%
Satisfied w overall experience:Strongly agree	79.5 116.9%
Satisfied w overall experience:Agree	20.5 30.1%
Satisfied w overall experience:Neutral	0 0%
Satisfied w overall experience:Disagree	0 0%
Satisfied w overall experience:Strongly Disagree	0 0%

4. Secondary Outcome

Title	Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population
Description	Changes in eye exam rates of the diabetic subset of total population from baseline (i.e. study entry) and post-enrollment in study. Baseline data were to be obtained from the UNC electronic medical record (EMR) as the number of participants with eye exams within the past year and post data would consist of the number of participants completing a study exam.
Time Frame	Baseline and post retinal eye exam

Outcome Measure Data

Analysis Population Description

Baseline retinal examination data were not present within the EMR; therefore, this analysis could not be performed.

Arm/Group Title	RetinaVue 100 Camera
Arm/Group Description	Participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera RetinaVue 100 camera: Images of the subject's retina will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit.
Measure Participants	0

5. Post-Hoc Outcome

Title	Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera
Time Frame	Up to as much as one year after study enrollment

Outcome Measure Data

Analysis Population Description

Diabetic dialysis participants

Arm/Group Title	RetinaVue 100 Camera
Arm/Group Description	Participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera RetinaVue 100 camera: Images of the subject's retina will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit.
Measure Participants	37
No retinopathy	11 16.2%
Retinopathy without referral	9 13.2%
Retinopathy with referral	17 25%

Adverse Events

Time Frame	The duration of the eye exam and the period following, up to a two hour interval.
Arm/Group Title	ESRD
Arm/Group Description	This study only had only one arm. All those individuals who met eligibility criteria and provided voluntary consent, were enrolled to this study and followed the same procedures.
All Cause Mortality
	ESRD
	Affected / at Risk (%)	# Events
Total	0/68 (0%)
Serious Adverse Events
	ESRD
	Affected / at Risk (%)	# Events
Total	0/68 (0%)
Other (Not Including Serious) Adverse Events
	ESRD
	Affected / at Risk (%)	# Events
Total	0/68 (0%)

Limitations/Caveats

Limitations included small sample size which led to low power.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.