Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
NCT ID: NCT02466607
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2015-03-31
2015-07-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
Study Groups
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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 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.
pupil dilation
Pupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5%
RETeval color flicker ERG
Compare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes.
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.
Interventions
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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.
pupil dilation
Pupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5%
Eligibility Criteria
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Inclusion Criteria
* volunteers able to get their pupil fully dilated
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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LKC Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Olga Kraszewska, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
LKC Technologies
Locations
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Wedgwood Optometry
Fort Worth, Texas, United States
Countries
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References
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Davis CQ, Kraszewska O, Manning C. Constant luminance (cd.s/m2) versus constant retinal illuminance (Td.s) stimulation in flicker ERGs. Doc Ophthalmol. 2017 Apr;134(2):75-87. doi: 10.1007/s10633-017-9572-3. Epub 2017 Feb 3.
Other Identifiers
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SAIRB-15-0017
Identifier Type: -
Identifier Source: org_study_id