Eye implant could restore sight in advanced AMD
NCT ID NCT04796545
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a small telescope-like implant placed inside the eye to improve vision in people with end-stage age-related macular degeneration (AMD). 76 participants aged 55 and older will receive the implant and be followed for 12 months. The goal is to see if the device safely improves both near and distance vision.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SING IMT 3X implant (a tiny telescope device surgically placed in the eye)
- What this could lead to
- If it works, this implant could help people with advanced AMD see better up close and far away, potentially improving daily life.
- What could go wrong
- This is a small, early-stage study with only 76 people. The implant requires eye surgery, which carries risks like infection or reduced corneal cells. It may not work for everyone.
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 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- 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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55 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: 1. Be 55 years of age or older. 2. Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT. 3. Have evidence of cataract. 4. Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes. 5. Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation. 6. Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately). 7. Have an ACD of at least 2.5 mm in the eye scheduled for surgery. 8. Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant. 9. Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed. 10. Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements. Exclusion Criteria: 1. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months. 2. Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye. 3. A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP\>22 mm Hg. 4. Corneal guttata. 5. Known sensitivity to post-operative medications. 6. Significant communication impairment or severe neurological disorders. 7. Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes. 8. An ocular condition that predisposes the patient to eye rubbing. 9. Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery. 10. Patients for whom the planned operative eye has: * Myopia \> 6.0 D * Hyperopia \> 4.0 D * Axial length \< 21 mm * Endothelial cell density \< 1600 cells per square mm * Narrow angle, i.e., \< Schaffer grade 2. 11. Inflammatory ocular disease. 12. Cornea stromal or endothelial dystrophies, including guttata. 13. Zonular weakness/instability of crystalline lens, or pseudoexfoliation. 14. Diabetic retinopathy. 15. Untreated retinal tears. 16. Retinal vascular disease. 17. Optic nerve disease. 18. A history of retinal detachment. 19. Retinitis pigmentosa. 20. Intraocular tumor. 21. Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study. 22. Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative. 23. Have a condition or be in a situation that, in the Investigator's opinion, may put the Subject at significant risk, may confound the study results, or may interfere significantly with the Subject's participation in the study.
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
12 sites in 7 countries. 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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Augenklinik Städtisches Klinikum Karlsruhe
TERMINATEDKarlsruhe, Germany
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CHRU de Strasbourg
RECRUITINGStrasbourg, France
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Centre d'Ophtalmologie Paradis-Monticelli
RECRUITINGMarseille, France
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Fondazione Policlinico Universitario Agostino Gemelli
RECRUITINGRoma, Italy
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Hospital Universitario La Luz - Quirónsalud
RECRUITINGMadrid, Spain
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Hélios Ophtalmologie, Saint-Jean-de-Luz
RECRUITINGSaint-Jean-de-Luz, France
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Institut OMIQ
RECRUITINGBarcelona, Spain
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Mater Misericordiae University Hospital
RECRUITINGDublin, Ireland
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Royal Victoria Hospital Belfast Health & Social Care Trust
RECRUITINGBelfast, United Kingdom
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UZ Brussel
RECRUITINGBrussels, Belgium
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Università degli Studi di Napoli Federico II
RECRUITINGNaples, Italy
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Universitätsklinikum Münster Klinik für Augenheilkunde
RECRUITINGMünster, Germany
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VISSUM
RECRUITINGAlicante, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A window into the eye: could functional tests predict macular degeneration progression?
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- Can a new eye injection save vision in wet AMD?
- A new eye camera may spot stressed cells before vision loss begins