RETeval All Comers Trial (REACT) (NCT03065881) | Clinical Trial Compass
CompletedNot Applicable
RETeval All Comers Trial (REACT)
United States664 participantsStarted 2017-02-13
Plain-language summary
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.
Who can participate
Age range
6 Months – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Retinal function assessed with an electroretinogram (ERG)