Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

Sponsor

LKC Technologies, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02466607

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinopathy	Device: RETeval color flicker ERG Device: RETeval dilated versus un-dilated flicker ERG Other: pupil dilation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: RETeval color flicker ERG Compare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes.	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.
Other: 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).	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%

Arm

Intervention/Treatment

Other: RETeval color flicker ERG

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

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.

Other: 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).

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%

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wedgwood Optometry	Fort Worth	Texas	United States	76133

Sponsors and Collaborators

LKC Technologies, Inc.

Investigators

Principal Investigator: Olga Kraszewska, Ph.D., LKC Technologies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LKC Technologies, Inc.

ClinicalTrials.gov Identifier:

NCT02466607

Other Study ID Numbers:

SAIRB-15-0017

First Posted:

Jun 9, 2015

Last Update Posted:

Jun 9, 2015

Last Verified:

Jun 1, 2015

Keywords provided by LKC Technologies, Inc.

Retinal function

Additional relevant MeSH terms:

Retinal Diseases

Study Results

No Results Posted as of Jun 9, 2015