Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

Not Applicable

• Conditions: Retinopathy
• Interventions: Device: RETeval dilated versus un-dilated flicker ERG; Device: RETeval color flicker ERG; Other: pupil dilation

• Registration Number: NCT02466607
• Lead Sponsor: LKC Technologies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Status Verified: 2015-06
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-08
• Last Update Submitted: 2015-06-08
• Study First Posted: 2015-06-09
• Last Update Posted: 2015-06-09
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
RETeval dilated versus un-dilated flicker ERG	RETeval dilated versus un-dilated flicker ERG	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).
RETeval color flicker ERG	RETeval color flicker ERG	Compare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes.
RETeval dilated versus un-dilated flicker ERG	pupil dilation	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).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wedgwood Optometry; 🇺🇸 Fort Worth, Texas, United States