NCT02466607

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

June 3, 2015

Last Update Submit

December 12, 2025

Conditions

Retinopathy

Keywords

Retinal function

Outcome Measures

Primary Outcomes (4)

  • Flicker harmonic amplitude

    up to 2 mnths

  • Flicker harmonic implicit time

    up to 2 months

  • Flicker fundamental amplitude

    up to 2 months

  • Flicker fundamental implicit time

    up to 2 months

Study Arms (2)

RETeval color flicker ERG

OTHER

Compare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes.

Device: RETeval color flicker ERG

RETeval dilated versus un-dilated flicker ERG

OTHER

Compare implicit times and amplitudes of ERGs obtained from cd/m2/sec stimulation (used with dilated pupils) to those obtained from troland stimulation (used with un-dilated pupils).

Device: RETeval dilated versus un-dilated flicker ERGOther: pupil dilation

Interventions

RETeval color flicker ERGDEVICE

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.

RETeval color flicker ERG
RETeval dilated versus un-dilated flicker ERGDEVICE

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.

RETeval dilated versus un-dilated flicker ERG
pupil dilationOTHER

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

RETeval dilated versus un-dilated flicker ERG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adult volunteers
  • volunteers able to get their pupil fully dilated

You may not qualify if:

  • pregnant women
  • children
  • subjects with
  • light sensitivity
  • photosensitive epilepsy
  • allergies or sensitivity to pupil dilation ophthalmic solutions
  • history of glaucoma
  • cardiac dysrhythmia will not be invited to participate in this study.
  • Pregnancy status, light sensitivity and photosensitive epilepsy will be based on volunteer's providing this information at the time of signing the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wedgwood Optometry

Fort Worth, Texas, 76133, United States

Location

Related Publications (1)

  • Davis CQ, Kraszewska O, Manning C. Constant luminance (cd.s/m2) versus constant retinal illuminance (Td.s) stimulation in flicker ERGs. Doc Ophthalmol. 2017 Apr;134(2):75-87. doi: 10.1007/s10633-017-9572-3. Epub 2017 Feb 3.

    PMID: 28160194DERIVED

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Olga Kraszewska, Ph.D.

    LKC Technologies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 9, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

US(1)