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RETeval Study for Diabetic Retinopathy

NCT01950663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2017-06-12

Study results available
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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.

Conditions

Interventions

DEVICE

RETeval

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.

Sponsors & Collaborators

  • LKC Technologies, Inc.

    collaborator INDUSTRY

  • National Eye Institute (NEI)

    collaborator NIH

  • Inoveon Corporation

    lead INDUSTRY

Principal Investigators

  • Stephen R Fransen, MD · Inoveon Corporation

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950663 on ClinicalTrials.gov