RETeval All Comers Trial (REACT)

Study Overview
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Brief Summary
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The primary objective of this study is to collect electroretinogram ERG measurements from visually normal and abnormal subjects using the FDA cleared RETeval device (K142567). Data from the visually normal subjects will be used to create reference intervals for the device. Secondary objectives of the study are to provide ERG waveforms representative of disease states encountered and to analyze how well an ERG detects the various disease states encountered.

Official Title
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RETeval All Comers Trial (REACT)

Conditions
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Retinal Disease, Electroretinogram

Intervention / Treatment
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* Device: RETeval


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All volunteers (age 0.5 to 95) willing to participate in the study as a part of their routine eye exam. While not specifically targeting vulnerable groups such as for example children and pregnant women, we invite them to participate in the study. Collecting normative data from these less represented populations is particularly difficult and we welcome the opportunity to gather these rare data. Subjects under the age of 18 will be included with the assent of the subject (for those at least 10 years of age) and consent from one parent/guardian (for those under age of 10). In any case patient is not able to provide the consent by him/her self and is willing to participate in the study the same person that is consenting for the routine eye exam can consent for the REACT study. Exclusion Criteria: Subjects with photosensitive epilepsy , allergies to pupil dilating agents, or history of cardiac dysrhythmia will not be invited to participate in this study. - Subjects with history of glaucoma can either be included in the group of non dilated subjects or can have dilated ERGs if the dilation was recommended by the health professional as the part of the routine eye exam. Exclusion criteria will be based on volunteer's providing this information at the time of signing the consent form. If patient is not aware of his photosensitive epilepsy and it occurs during the recording, the test will be interrupted immediately. Statistically, 1 person out of 3600 people can suffer from photosensitive epilepsy in US. There is a rather small possibility we will encounter such a person during the collection of ERGs from the group of 1000 volunteers

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dilated versus Natural pupil<br> | Device: RETeval<br>* The RETeval device measures the retina's electrical response to light, called an electroretinogram (ERG). The standards body ISCEV [1] recommends collecting normative data for ERGs to provide waveforms and statistically relevant measurements representing the range of ERGs from people with normal vision. LKC Technologies provides this information with their UTAS product line and wishes to collect such a database for the newest device: the RETeval device. As the RETeval device uses a different electrode to measure the ERG, the normal data for the UTAS product line is not transferable to the RETeval device. Ophthalmic practitioners would also like ERG examples of specific retinal disorders to help diagnose patients with abnormal ERGs. The RETeval device is FDA cleared (K142567),<br>|
| Active Comparator: Normal retina versus abnormal retina<br> | Device: RETeval<br>* The RETeval device measures the retina's electrical response to light, called an electroretinogram (ERG). The standards body ISCEV [1] recommends collecting normative data for ERGs to provide waveforms and statistically relevant measurements representing the range of ERGs from people with normal vision. LKC Technologies provides this information with their UTAS product line and wishes to collect such a database for the newest device: the RETeval device. As the RETeval device uses a different electrode to measure the ERG, the normal data for the UTAS product line is not transferable to the RETeval device. Ophthalmic practitioners would also like ERG examples of specific retinal disorders to help diagnose patients with abnormal ERGs. The RETeval device is FDA cleared (K142567),<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal function assessed with an electroretinogram (ERG) | Response of the retina exposed to the flashes of light. ERG describes retinal function. | 1 year |