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Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

NCT02466607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-17

No results posted yet for this study

Summary

The electroretinogram (ERG) is a diagnostic test that measures the electrical activity generated by cells in the retina in response to a light stimulus. Typically, an ERG is recorded with white flash when the pupil is dilated. RETeval Visual Diagnostic Device (RETeval) generates an array of color flashes, which allows studying whether color flash would be a useful diagnostic tool.

Full pupil dilation is required to obtain a response from the whole retina. However, this requirement often limits a patient's flow in the clinic and increases the overall time patients spend at the eye practitioner. RETeval provides the possibility of recording ERGs in un-dilated pupils therefore making the whole exam easier and shorter. These results need to be compared to the classic, fully dilated ERG and evaluated for efficiency.

The purpose of this research study is to use the RETeval device to measure the eye's electrical response and how it changes with different stimuli such as changing flash color or pupil dilation.

Conditions

  • Retinopathy

Interventions

DEVICE

RETeval color flicker ERG

Flicker ERGs obtained to 56 CIE 1931 (created by the International Commission on Illumination (CIE) in 1931) colors series. White flash of 0,33, 0,33 was used for comparison.

DEVICE

RETeval dilated versus un-dilated flicker ERG

Two series of white flashes: 3,0 cd/m2/sec and Trolands equivalent assuming 3,7 mm pupil size, delivered at 3 min interval over 30 min.

OTHER

pupil dilation

Pupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5%

Sponsors & Collaborators

  • LKC Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Olga Kraszewska, Ph.D. · LKC Technologies

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-07-31
Completion
2015-07-31

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 NCT02466607 on ClinicalTrials.gov