CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 468 enrolled
Drug / intervention
RETevaldevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01950663
NCT01950663N/ACompleted
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RETeval Calibration / Validation Study - Diabetic Retinopathy

Inoveon Corporation·interventional·Posted Sep 25, 2013·Updated Jun 12, 2017

In Brief

A clinical study evaluating RETeval for Diabetic Retinopathy. Completed, enrolled 468 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Retinopathy
CountriesUnited States
CollaboratorsLKC Technologies, Inc., National Eye Institute (NEI)

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 25, 2013
Enrollment StartSep 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.8 years ago

Interventions

RETevaldevice

RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.