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.
Study ID
NCT04796545
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SING IMT(TM) System, model NG SI IMT 3X — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Mar 15, 2021
Start date
Sep 13, 2022
Status verified
Nov 2025
Primary completion
Feb 28, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
76 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: SING IMT System model NG SI IMT 3X
    All participants will be implanted with the SING IMT System model NG SI IMT 3X.

Primary Outcome Measure

Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system [ Time Frame: 12 months ]

Central Contacts

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