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Eye implant could restore sight in advanced AMD

NCT ID NCT04796545

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

55 years and older

Sex

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Augenklinik Städtisches Klinikum Karlsruhe

    TERMINATED

    Karlsruhe, Germany

  • CHRU de Strasbourg

    RECRUITING

    Strasbourg, France

  • Centre d'Ophtalmologie Paradis-Monticelli

    RECRUITING

    Marseille, France

  • Fondazione Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, Italy

  • Hospital Universitario La Luz - Quirónsalud

    RECRUITING

    Madrid, Spain

  • Hélios Ophtalmologie, Saint-Jean-de-Luz

    RECRUITING

    Saint-Jean-de-Luz, France

  • Institut OMIQ

    RECRUITING

    Barcelona, Spain

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, Ireland

  • Royal Victoria Hospital Belfast Health & Social Care Trust

    RECRUITING

    Belfast, United Kingdom

  • UZ Brussel

    RECRUITING

    Brussels, Belgium

  • Università degli Studi di Napoli Federico II

    RECRUITING

    Naples, Italy

  • Universitätsklinikum Münster Klinik für Augenheilkunde

    RECRUITING

    Münster, Germany

  • VISSUM

    RECRUITING

    Alicante, Spain

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Other studies related to the condition(s) this trial covers.