NCT03392324Completed
PRIMA US-Feasibility Study in Atrophic Dry AMD
Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Atrophic Dry Age Related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
In this early feasibility trial the safety and performance of the new retinal prothesis PRIMA is tested in five subjects suffering from atrophic dry age related macular degeneration.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 29 Dec 2017
- Start date
- 26 Apr 2018
- Primary completion date
- 20 May 2026
- Lead sponsor
- Science Corporation
- Diseases
- Macular degeneration
- NCT number
- NCT03392324
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 26 Apr 2018 to the primary completion date, 20 May 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Is 60 years or older at the date of inclusion;
- Has a confirmed diagnosis of atrophic dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters in the study eye;
- Has best corrected visual acuity of logMAR 1.3 (20/400) or worse in the study eye measured by ETDRS;
- Has a central scotoma in the study eye with no perception at 0 dB on MP-1 micro-perimetry scale in the visual field covering the central 7 degrees (+/-3.5 degrees) and maximum 20% perception in the remaining visual field covering the central 12 degrees (+/- 6 degrees);
- Meets one of the following criteria in the non-study eye:
- Visual acuity of 20/200 (logMAR 1.0) or worse and an atrophy size \<8mm2
- Visual acuity of 20/160 (logMAR 0.9) or worse and an atrophy size ≥8mm2 and ≤12.5 mm2
- Visual acuity of 20/100 (logMAR 0.7) or worse and an atrophy size \>12.5 mm2
- Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients);
- Understands and accepts the obligation to present for all schedule follow-up visits;
- Patient signed informed consent.
- Main Exclusion Criteria:
- Has cataract in the study ;
- Has an aphakic study eye;
- Has no light perception in the study eye;
- Has a history of choroidal neovascularization in either eye;
- Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye
- Has an implanted telescope in one eye;
- Has any disease or condition that prevents adequate examination of the study
- Has a corneal endothelial cell count of less than 1000 cells/mm² in the study eye
- Suffers from nystagmus or other ocular motility disorders;
- Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols
- Has a history of epileptic seizure;
- Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study;
- Presents with hypotony or hypertony in the study eye;
- Has another active implanted device;
- Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis;
- Is an immune-suppressed subject;
- Is carrier of multi-resistant microorganisms;
- Is receiving anticoagulation therapy that cannot be adapted to allow eye surgery;
- Is participating in another investigational drug or device study that may interfere with the present study;
- Has recurrent or chronic inflammations or infections;
- Has a severe psychological disorder;
- Does not have the mental capacity to legally sign the informed consent;
- Has severe renal, cardiac, hepatic, etc. organ diseases;
- Has head dimensions that are incompatible with the Visual Interface;
- Has too high and unrealistic expectation;
- Detailed patient criteria will be verified by the study doctor.
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bascom Palmer Eye Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Byers Eye Institute, Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| UPMC Eye Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.