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Completed

NCT Number: NCT02466607

Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

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.

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Key information

Conditions

Retinopathy Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wedgwood Optometry

Fort Worth, Texas, 76133, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

RETeval color flicker ERG

Device

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 dilated versus un-dilated flicker ERG

Device

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.

pupil dilation

Other

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

Primary outcomes

  1. Flicker harmonic amplitude

    Time frame: up to 2 mnths

  2. Flicker harmonic implicit time

    Time frame: up to 2 months

  3. Flicker fundamental amplitude

    Time frame: up to 2 months

  4. Flicker fundamental implicit time

    Time frame: up to 2 months

Sponsors and collaborators

Lead sponsor

LKC Technologies, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2015
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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