Bionic eye implant aims to restore sight in dry AMD patients
NCT ID NCT03392324
First seen Jun 24, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This early feasibility trial tests a new retinal implant called PRIMA in 5 people with advanced dry age-related macular degeneration who have lost central vision. The device is surgically placed in the eye to stimulate remaining retinal cells. Researchers are checking if it is safe and whether it can improve near vision and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PRIMA retinal implant (device)
- What this could lead to
- If it works, this could point toward a way to restore some vision in people with advanced dry age-related macular degeneration.
- What could go wrong
- This is a very early, small trial with only 5 participants. The implant may not improve vision enough to be useful, and surgery carries risks like infection or device failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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5 people
The number who actually took part.
- Started
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Apr 2018
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
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Byers Eye Institute-Stanford University
Palo Alto, California, 94303, United States
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UPMC Eye Center
Pittsburgh, Pennsylvania, 15213, United States
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Other studies related to the condition(s) this trial covers.
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