PRIMA US-Feasibility Study in Atrophic Dry AMD (PRIMA-FS-US)

This is an interventional treatment trial for Dry Age-related Macular Degeneration focused on measuring atrophic macular degeneration, geographic atrophy, retina implant, retinal prosthesis, visual prosthesis, macular degeneration, dry macular degeneration, AMD Read More

Inclusion Criteria:

• 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.