N/A
N=68
Feasibility Study of Retinal Screening Using the RetinaVue 100 Camera in Outpatient Dialysis Centers
Kidney Failure, Chronic · Eye Diseases · Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT02823600 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Usability of the RetinaVue Hand-Held 100 Camera — 20; 116 Retinal Images
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RetinaVue 100 camera (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability of the RetinaVue Hand-Held 100 Camera |
20; 116 | — |
| SECONDARY Overall Retinopathy in a Dialysis Population |
33; 35 | — |
| SECONDARY Participant Satisfaction |
61.5; 28.2; 10.3; 0; 0; 75.4 | — |
| SECONDARY Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02823600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.