Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04796545
NA

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

Sponsor: VisionCare, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2022-09-13

Completion Date

2028-12

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DEVICE

SING 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