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RETeval All Comers Trial (REACT)

NCT03065881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2025-12-17

No results posted yet for this study

Summary

The primary objective of this study is to collect electroretinogram ERG measurements from visually normal and abnormal subjects using the FDA cleared RETeval device (K142567). Data from the visually normal subjects will be used to create reference intervals for the device. Secondary objectives of the study are to provide ERG waveforms representative of disease states encountered and to analyze how well an ERG detects the various disease states encountered.

Conditions

  • Retinal Disease, Electroretinogram

Interventions

DEVICE

RETeval

The RETeval device measures the retina's electrical response to light, called an electroretinogram (ERG). The standards body ISCEV \[1\] recommends collecting normative data for ERGs to provide waveforms and statistically relevant measurements representing the range of ERGs from people with normal vision. LKC Technologies provides this information with their UTAS product line and wishes to collect such a database for the newest device: the RETeval device. As the RETeval device uses a different electrode to measure the ERG, the normal data for the UTAS product line is not transferable to the RETeval device. Ophthalmic practitioners would also like ERG examples of specific retinal disorders to help diagnose patients with abnormal ERGs. The RETeval device is FDA cleared (K142567),

Sponsors & Collaborators

  • LKC Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-13
Primary Completion
2021-12-21
Completion
2021-12-21
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03065881 on ClinicalTrials.gov