Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Re… (NCT03333954) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Related Macular Degeneration
France5 participantsStarted 2017-11-06
Plain-language summary
In this study, the principle functionality of the device will be tested in humans for the first time. The study will evaluate the extent to which patients with atrophic dry age related macular degeneration (AMD) have evoked light perception using the implant.
Who can participate
Age range
60 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:
* Is 60 years or older at the date of enrolment;
* Has a confirmed diagnosis of advanced dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters;
* Has best corrected visual acuity of the study eye of logMAR 1.3 (20/400) or worse measured by ETDRS;
* Has no foveal perception measured by micro-perimetry in the study eye (≤ 4 dB on Opko scale or equivalent) ;
* Has a study eye that is able to perceive light;
* Has useful vision on the non-study eye;
* Has a refraction of study eye between -3 and + 4 (limits included) for patient with IOL (there is no refraction criteria for patients with natural lens);
* Understands and accepts the obligation to present for all schedule follow-up visits.
* Patient signed informed consent
Exclusion Criteria:
* Has cataracts that may influence the visual function of the study eye;
* Has an aphakic study eye
* Had cataract surgery in the last 1 month;
* Active sub-macular choroidal neovascularization in the study eye;
* Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, retinal detachment, infectious or inflammatory retinal disease, severe glaucoma, optic neuropathy, myopic chorio-retinal atrophy etc.);
* Has an implanted telescope in one eye;
* Has any disease or condition that prevents adequate examination of the study eye including, but not limited …
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.