MedTrace Logo

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

NCT07164378 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Age - Related Macular Degeneration (AMD)

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.

Sponsors & Collaborators

  • VisionCare, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2026-12-30
Completion
2027-04-30

Countries

  • France
  • Germany
  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164378 on ClinicalTrials.gov