Tiny nanowire implant aims to restore sight in rare eye disease
NCT ID NCT05853107
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This pilot study is testing a new retinal implant called AuTNA I in 7 people with retinitis pigmentosa, a genetic condition that causes progressive vision loss. The implant, a tiny array of nanowires placed under the retina, is designed to replace damaged light-sensing cells. Researchers will check safety and measure any vision improvements over one year using eye tests, brain scans, and electrical activity tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AuTNA I retinal prosthesis (nanoparticle-decorated titanium dioxide nanowire array device implanted under the retina)
- What this could lead to
- If successful, this could offer a new way to restore some vision in people with retinitis pigmentosa who have lost sight.
- What could go wrong
- This is a very early pilot study with only 7 people, so results may not apply widely. The implant is a new device, and risks like surgical complications or lack of vision improvement are possible.
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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About 7 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 to 70 years
- 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: 1. Age: 18-70 years of age. 2. Clinically diagnosed as retinitis pigmentosa (one of the following two conditions): ① typical triadfundus manifestations: "osteoblastic" pigmentation of retina, arterial stenosis, and waxy atrophy of optic disc. ② typical fundus changes with both a and b, with or without c: 1. poor night vision before vision loss; 2. standard 5 ERG examination showing more severely damaged scotopic response than photopic, even non response 3. impaired peripheral visual field in perimetry (when the patient's vision permits). 3. No or suspicious light perception in the eye for AuTNA I implantation. 4. Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization. 5. Voluntary to participate in the study and sign the informed consent. Exclusion Criteria: 1. Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc. 2. Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/L with medication); 3. Allergic constitution. 4. Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc. 5. Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc. 6. Habits of rubbing the eyes. 7. Compromised liver function (ALT and AST 1.5 times over the normal limits), renal function (Cr 1.5 times over the normal limits), coagulation function (APTT 1.5 times over the normal limits). 8. Pregnancy, lactating or planning to be pregnant within 6 months. 9. History of epilepsy or serious psychiatric diseases. 10. Other local or systemic diseases that may affect the vision. 11. Participation in other clinical trials within 1 month before this study. 12. Other conditions that the researcher found imporper to be included into this study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chunhui Jiang
RECRUITINGShanghai, Shanghai Municipality, 200030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a single eye injection restore sight in genetic blindness?
- A sharper look at the retina: new imaging technology may spot eye disease earlier
- Stem cell eye transplant aims to halt blindness from rare genetic disease
- Could stem cells restore sight in damaged eyes?
- Gene therapy injection aims to restore sight in rare blindness
- Ground-Level vision test could help retinitis pigmentosa patients walk better