Bionic implant shows promise for restoring sight in dry AMD
NCT ID NCT03333954
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a tiny implant called the PRIMA Bionic Vision System in 5 people with advanced dry age-related macular degeneration who had lost central vision. The implant is placed under the retina and uses electrical stimulation to replace damaged light-sensing cells. The goal was to see if the device could create visual perceptions, potentially helping patients see shapes and objects again.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PRIMA Bionic Vision System (sub-retinal implant)
- What this could lead to
- If it works, this could provide partial vision restoration for people blinded by dry age-related macular degeneration.
- What could go wrong
- This is a very early feasibility study with only 5 participants, so results may not apply widely. The implant only partially restores vision and does not cure the underlying disease.
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
-
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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Nov 2017
- Finished
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Dec 2024
- 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
-
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 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 to, corneal degeneration that cannot be resolved prior to implantation. Note, that this criterion is also important for the function of the implant; * Has an endothelia cell count of less than 1000 cells/mm² in the study eye; * Suffers from nystagmus; * Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness, severe multiple sclerosis, amyotrophic lateral sclerosis, severe neuritis, etc); * Has a history of epileptic seizure; * Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study; * Has a known sensitivity to the contact materials of the implant (iridium oxide, silicon-carbide and titanium); * Presents with hypotony in the study eye; * Presents with hypertony in the study eye; * Has another active implanted device (e.g. cochlear implant, pacemaker) that may interfere with the device function, or diagnoses requiring such an active implant; * Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis; * Is an immune-suppressed subject (e.g., due to HIV positive diagnosis, etc.); * Is carrier of multi-resistant germs; * 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; * Patients with recurrent or chronic inflammations or infections are excluded from the study. Specifically, patients with the following disorders are excluded: * Common inflammation - severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease); * Active inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, hordeolum, chalazion); * Has a severe psychological disorder. When in any doubt, an expert assessment needs to be arranged to clarify whether the patient's psychological health is suitable for the trial. In any doubts of the subjects psychological status a clinical psychologist, psychologist or the community doctor/general practitioner should be involved. The patient must have the legal capacity to sign the informed consent; * Has severe renal, cardiac, hepatic etc. organ diseases; * Has head dimension that are incompatible with the Visual Interface. * Has too high and unrealistic expectation (e.g., believes that a benefit is guaranteed or expect normal vision after surgery)
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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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Fondation Ophtalmologique A. De Rothschild/ Hopital des Quinze Vingts/
Paris, 75019, France
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