Trial Outcomes & Findings for Feasibility Study of Retinal Screening Using the RetinaVue 100 Camera in Outpatient Dialysis Centers (NCT NCT02823600)
NCT ID: NCT02823600
Last Updated: 2018-07-20
Results Overview
Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
baseline visit
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
RetinaVue 100 Camera
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.
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|---|---|
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Overall Study
STARTED
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68
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Overall Study
COMPLETED
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68
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study of Retinal Screening Using the RetinaVue 100 Camera in Outpatient Dialysis Centers
Baseline characteristics by cohort
| Measure |
RetinaVue 100 Camera
n=68 Participants
All participants will have a retinal eye exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera
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|---|---|
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Age, Customized
No retinopathy
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54.7 years
STANDARD_DEVIATION 18.1 • n=5 Participants
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Age, Customized
Retinopathy without referral
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60.0 years
STANDARD_DEVIATION 6.6 • n=5 Participants
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Age, Customized
Retinopathy with referral
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57.1 years
STANDARD_DEVIATION 11.6 • n=5 Participants
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Sex/Gender, Customized
Female : No retinopathy
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17 Participants
n=5 Participants
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Sex/Gender, Customized
Female : Retinopathy without referral
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6 Participants
n=5 Participants
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Sex/Gender, Customized
Female : Retinopathy with referral
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6 Participants
n=5 Participants
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Sex/Gender, Customized
Male : No retinopathy
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16 Participants
n=5 Participants
|
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Sex/Gender, Customized
Male : Retinopathy without referral
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5 Participants
n=5 Participants
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Sex/Gender, Customized
Male : Retinopathy with referral
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18 Participants
n=5 Participants
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Race/Ethnicity, Customized
African American: No retinopathy
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14 Participants
n=5 Participants
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Race/Ethnicity, Customized
African American: Retinopathy without referral
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6 Participants
n=5 Participants
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Race/Ethnicity, Customized
African American: Retinopathy with referral
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11 Participants
n=5 Participants
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Race/Ethnicity, Customized
Caucasian: No retinopathy
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11 Participants
n=5 Participants
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Race/Ethnicity, Customized
Caucasian: Retinopathy without referral
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3 Participants
n=5 Participants
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Race/Ethnicity, Customized
Caucasian: Retinopathy with referral
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8 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic: No retinopathy
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8 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic: Retinopathy without referral
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic: Retinopathy with referral
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4 Participants
n=5 Participants
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Race/Ethnicity, Customized
Data Missing
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1 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Diabetes: No retinopathy
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7 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Diabetes: Retinopathy without referral
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8 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Diabetes: Retinopathy with referral
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13 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Hypertension: No retinopathy
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12 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Hypertension: Retinopathy without referral
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1 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Hypertension: Retinopathy with referral
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7 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Other: No retinopathy
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13 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Other: Retinopathy without referral
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2 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Other: Retinopathy with referral
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4 Participants
n=5 Participants
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End-Stage Renal Disease Etiology
Data Missing
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7 Participants
n=5 Participants
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Diabetic dialysis population
Diabetes: Yes
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37 Participants
n=5 Participants
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Diabetic dialysis population
Diabetes: No
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31 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: baseline visitUsability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.
Outcome measures
| Measure |
Images
n=136 Retinal Images
This group is the total number of images, 136, captured from the study population.
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|---|---|
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Usability of the RetinaVue Hand-Held 100 Camera
Inadequate Images
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20 Retinal Images
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Usability of the RetinaVue Hand-Held 100 Camera
Adequate Images
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116 Retinal Images
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SECONDARY outcome
Timeframe: Post retinal eye examNumber of participants found to have retinopathy in a dialysis population
Outcome measures
| Measure |
Images
n=68 Participants
This group is the total number of images, 136, captured from the study population.
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|---|---|
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Overall Retinopathy in a Dialysis Population
No retinopathy
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33 Participants
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Overall Retinopathy in a Dialysis Population
Retinopathy
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35 Participants
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SECONDARY outcome
Timeframe: Post retinal eye examPopulation: This analysis is based on responses from the 39 that completed the survey.
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.
Outcome measures
| Measure |
Images
n=39 Participants
This group is the total number of images, 136, captured from the study population.
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|---|---|
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Participant Satisfaction
Satisfied time complete eye exam:Strongly agree
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61.5 Percentage of participants
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Participant Satisfaction
Satisfied time complete eye exam : Agree
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28.2 Percentage of participants
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Participant Satisfaction
Satisfied time complete eye exam : Neutral
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10.3 Percentage of participants
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Participant Satisfaction
Satisfied time complete eye exam:Disagree
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0 Percentage of participants
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Participant Satisfaction
Satisfied time complete eye exam:Strongly Disagree
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0 Percentage of participants
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Participant Satisfaction
Comfort during eye exam : Strongly agree
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75.4 Percentage of participants
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Participant Satisfaction
Comfort during eye exam : Agree
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24.6 Percentage of participants
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Participant Satisfaction
Comfort during eye exam : Neutral
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0 Percentage of participants
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Participant Satisfaction
Comfort during eye exam : Disagree
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0 Percentage of participants
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Participant Satisfaction
Comfort during eye exam : Strongly Disagree
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0 Percentage of participants
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Participant Satisfaction
Comfort after eye exam : Strongly agree
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82.0 Percentage of participants
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Participant Satisfaction
Comfort after eye exam : Agree
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18.0 Percentage of participants
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Participant Satisfaction
Comfort after eye exam : Neutral
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0 Percentage of participants
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Participant Satisfaction
Comfort after eye exam : Disagree
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0 Percentage of participants
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Participant Satisfaction
Comfort after eye exam : Strongly Disagree
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0 Percentage of participants
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Participant Satisfaction
1st eye quick recovery:Strongly agree
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53.9 Percentage of participants
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Participant Satisfaction
1st eye quick recovery:Agree
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41.0 Percentage of participants
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Participant Satisfaction
1st eye quick recovery:Neutral
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5.1 Percentage of participants
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Participant Satisfaction
1st eye quick recovery:Disagree
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0 Percentage of participants
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Participant Satisfaction
1st eye quick recovery:Strongly Disagree
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0 Percentage of participants
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Participant Satisfaction
2nd eye quick recovery:Strongly agree
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59.0 Percentage of participants
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Participant Satisfaction
2nd eye quick recovery:Agree
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35.9 Percentage of participants
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Participant Satisfaction
2nd eye quick recovery:Neutral
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5.1 Percentage of participants
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Participant Satisfaction
2nd eye quick recovery :Disagree
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0 Percentage of participants
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Participant Satisfaction
2nd eye quick recovery:Strongly Disagree
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0 Percentage of participants
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Participant Satisfaction
Satisfied w overall experience:Strongly agree
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79.5 Percentage of participants
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Participant Satisfaction
Satisfied w overall experience:Agree
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20.5 Percentage of participants
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Participant Satisfaction
Satisfied w overall experience:Neutral
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0 Percentage of participants
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Participant Satisfaction
Satisfied w overall experience:Disagree
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0 Percentage of participants
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Participant Satisfaction
Satisfied w overall experience:Strongly Disagree
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0 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline and post retinal eye examPopulation: Baseline retinal examination data were not present within the EMR; therefore, this analysis could not be performed.
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.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Up to as much as one year after study enrollmentPopulation: Diabetic dialysis participants
Outcome measures
| Measure |
Images
n=37 Participants
This group is the total number of images, 136, captured from the study population.
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|---|---|
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Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera
No retinopathy
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11 Participants
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Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera
Retinopathy without referral
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9 Participants
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Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera
Retinopathy with referral
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17 Participants
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Adverse Events
ESRD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Seema Garg, MD, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-5296
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place