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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.
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
Conditions
Interventions
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