Retinopathy
Conditions
Keywords
Retinal function
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.
Interventions
DEVICERETeval 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.
DEVICERETeval 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.
OTHERpupil dilation
Pupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5%
Sponsors
LKC Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed