- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02466607
Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olga Kraszewska, Ph.D.
- Phone Number: 682-551-2601
- Email: olgakraszewska.phd@gmail.com
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76133
- Recruiting
- Wedgwood Optometry
-
Contact:
- Olga Kraszewska, Ph.D.
- Phone Number: 682-551-2601
- Email: olgakraszewska.phd@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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).
|
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 will be dilated using Proparacaine 0.5% and Tropicamide 0.5%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Flicker harmonic amplitude
Time Frame: up to 2 mnths
|
up to 2 mnths
|
Flicker harmonic implicit time
Time Frame: up to 2 months
|
up to 2 months
|
Flicker fundamental amplitude
Time Frame: up to 2 months
|
up to 2 months
|
Flicker fundamental implicit time
Time Frame: up to 2 months
|
up to 2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olga Kraszewska, Ph.D., LKC Technologies
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAIRB-15-0017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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