N/A
N=468
RETeval Study for Diabetic Retinopathy
Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT01950663 ↗Enrolled (actual)
468
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Per Patient Referral Accuracy — 318 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RETeval (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inoveon Corporation
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Per Patient Referral Accuracy |
318 | — |
Summary
RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy. The purpose of this study is to calibrate RETeval, and then measure its ability to detect vision threatening diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS) 7-field, dilated, stereo, color fundus photography, read according to the ETDRS protocol, will be used as the gold standard.
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with diabetes and treated with at least one oral hypoglycemic medication or insulin
- Eighteen years or older
Exclusion Criteria
- History of photosensitive epilepsy
- Previous laser or drug treatment for diabetic retinopathy or macular edema
- Eye diseases other than diabetic retinopathy or macular edema that, in the opinion of the recruiting ophthalmologist, may affect the electroretinogram or result in ungradable Early Treatment Diabetic Retinopathy Study Protocol images.
- Inability or unwillingness of the subject or legal guardian/representative to give written informed consent
Data sourced from ClinicalTrials.gov (NCT01950663). 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.