RecruitingNot ApplicableNCT04796545

Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration

A Prospective, Multicenter Post-marketing Clinical Investigation of the SING IMT(TM) System, Model NG SI IMT 3X in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration


Sponsor

VisionCare, Inc.

Enrollment

76 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD). Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is following patients who receive the NG SI IMT 3X — a miniature telescope implanted inside the eye — to treat advanced age-related macular degeneration (AMD). AMD destroys the central vision needed for reading and recognizing faces, and in its end stage leaves patients with only peripheral (side) vision. The implantable telescope magnifies central images onto a healthier area of the retina, effectively giving patients usable central vision again for many daily tasks. The study monitors how well the implant performs and how safe it is in real-world patients over the medium to long term. Participants will undergo vision testing, eye examinations, and training programs to learn how to use the device effectively. You may be eligible if... - You are 55 years or older - You have end-stage AMD (geographic atrophy or disciform scar) involving the central area of both eyes - You have cataracts in the eye to be operated on - Your best-corrected vision in both eyes is between 20/80 and 20/800 - You have adequate peripheral vision in the non-operated eye - You show at least a 5-letter improvement using a telescope simulator - You are willing and able to participate in the post-operative training program You may NOT be eligible if... - You have active choroidal neovascularization (wet AMD) or were treated for it in the last 6 months - You have a history of retinal detachment, retinal vascular disease, or optic nerve disease - You have diabetic retinopathy or retinitis pigmentosa - You have glaucoma or elevated eye pressure (>22 mmHg) - You have had previous surgery in the operative eye - You have a high degree of myopia (>6.0 D) or hyperopia (>4.0 D) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESING IMT(TM) System, model NG SI IMT 3X

The SING IMT 3X implant is a visual prosthetic implantable device, which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with bilateral, end-stage age-related macular degeneration.


Locations(13)

UZ Brussel

Brussels, Belgium

Centre d'Ophtalmologie Paradis-Monticelli

Marseille, France

Hélios Ophtalmologie, Saint-Jean-de-Luz

Saint-Jean-de-Luz, France

CHRU de Strasbourg

Strasbourg, France

Augenklinik Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

Universitätsklinikum Münster Klinik für Augenheilkunde

Münster, Germany

Mater Misericordiae University Hospital

Dublin, Ireland

Università degli Studi di Napoli Federico II

Naples, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

VISSUM

Alicante, Spain

Institut OMIQ

Barcelona, Spain

Hospital Universitario La Luz - Quirónsalud

Madrid, Spain

Royal Victoria Hospital Belfast Health & Social Care Trust

Belfast, United Kingdom

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NCT04796545


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