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RECRUITING
NCT07164378
NA

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.

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Lens-Exchange

The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus

PROCEDURE

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