NCT02466607

Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: LKC Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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%

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-06-09
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States