Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

Retinopathy Clinical Trial

Official title:

Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02466607
• Other study ID #: SAIRB-15-0017
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2015
• Last updated: June 8, 2015
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: June 2015
• Source: LKC Technologies, Inc.
• Contact: Olga Kraszewska, Ph.D.
• Phone: 682-551-2601
• Email: olgakraszewska.phd[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Retinopathy

Intervention

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.
• 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%

Locations

Country	Name	City	State
United States	Wedgwood Optometry	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LKC Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flicker harmonic amplitude		up to 2 mnths	No
Primary	Flicker harmonic implicit time		up to 2 months	No
Primary	Flicker fundamental amplitude		up to 2 months	No
Primary	Flicker fundamental implicit time		up to 2 months	No