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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

NCT04796545 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • AMD
  • Age-Related Macular Degeneration

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.

Sponsors & Collaborators

  • VisionCare, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2027-02-28
Completion
2028-12-31

Countries

  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04796545 on ClinicalTrials.gov