Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
5 participants
INTERVENTIONAL
2018-04-26
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PRIMA
Implantation of PRIMA device
PRIMA
Implantation of PRIMA device
Interventions
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PRIMA
Implantation of PRIMA device
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
60 Years
ALL
No
Sponsors
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Science Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Martel, MD
Role: PRINCIPAL_INVESTIGATOR
UPMC Pittsburgh
Locations
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Byers Eye Institute-Stanford University
Palo Alto, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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Pixium Vision
Other Identifiers
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CIP-PRIMA-FS-US
Identifier Type: -
Identifier Source: org_study_id