Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02466607|
Recruitment Status : Unknown
Verified June 2015 by LKC Technologies, Inc..
Recruitment status was: Recruiting
First Posted : June 9, 2015
Last Update Posted : June 9, 2015
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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 :||March 2015|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
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.
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%
- Flicker harmonic amplitude [ Time Frame: up to 2 mnths ]
- Flicker harmonic implicit time [ Time Frame: up to 2 months ]
- Flicker fundamental amplitude [ Time Frame: up to 2 months ]
- Flicker fundamental implicit time [ Time Frame: up to 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466607
|Contact: Olga Kraszewska, Ph.D.||firstname.lastname@example.org|
|United States, Texas|
|Fort Worth, Texas, United States, 76133|
|Contact: Olga Kraszewska, Ph.D. 682-551-2601 email@example.com|
|Principal Investigator:||Olga Kraszewska, Ph.D.||LKC Technologies|