Clinical Research Directory
Browse clinical research sites, groups, and studies.
International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study
Sponsor: VisionCare, Inc.
Summary
This study aims to expand the CE mark IFU of the SING IMT™ to pseudophakic (patients with an intraocular lents) patients with late stage of AMD (Age-Related Macular Degeneration) and bilateral central vision impairment. This randomized, international, multicenter study will evaluate the safety and efficacy of the device in this patient group. Findings will support regulatory submissions, clinical decision-making, and potential label expansion.
Official title: Prospective, MulticEnter, Randomized, International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study
Key Details
Gender
All
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-09-23
Completion Date
2027-04-30
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Lens-Exchange
The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus
Add-on
The SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus.
Locations (12)
Centre d'Ophtalmologie Paradis-Monticelli
Marseille, France
Hélios Ophtalmologie
Saint-Jean-de-Luz, France
CHU de Strasbourg
Strasbourg, France
Asklepios Augenklinik Nord-Heidberg
Hamburg, Germany
Augenklinik Sulzbach
Sulzbach, Germany
MVZ Augenklinik Petrisberg GmbH
Trier, Germany
Augenklinik und Poliklinik des Universitätsklinikums
Würzburg, Germany
Ospedale Generale Regionale "F. Miulli"
Bari, Italy
IRCCS Humanitas
Bergamo, Italy
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
Presidio Ospedaliero Palagi
Florence, Italy
Policlinico Universitario Fondazione Agostino Gemelli
Roma, Italy