A Study of the Implantable Miniature Telescope, Model SING (SING IMT) in Patients With Central Vision Impairment Associated With End-stage Age Related Macular Degeneration in an Israeli Cohort

VisionCare, Inc.1 site in 1 country5 target enrollmentJuly 30, 2023

ConditionsAge-Related Macular Degeneration Geographic Atrophy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Age-Related Macular Degeneration
Sponsor: VisionCare, Inc.
Enrollment: 5
Locations: 1
Primary Endpoint: Safety: Endothelial cell density
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this single center study is to determine the safety of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in a small sample of patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD) in an Israeli Cohort

Detailed Description

The SING IMT has CE Mark in the EU and has been implanted in over 200 patients globally including a pivotal study in the U.S. currently underway (the Concerto Study) and a post-marketing study in EU (The PMCF Study). Model SING is a new injectable model based on the IMT parent model (PMA P050034). Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with refraction, and also when using an external telescope simulator to determine if they are likely to benefit from receiving the SING IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery in one eye. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 10 rehabilitation/training visits with a low vision specialist to learn how to use the fellow eye for ambulation and the eye with the implant for magnified viewing during daily activities.

Registry

clinicaltrials.gov

Start Date

July 30, 2023

End Date

January 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

VisionCare, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For Both Eyes:
•Be at least 55 years of age at the Pre-operative Visit;
•Have ETDRS BCDVA 0.6 to 1.6 logMAR (20/80 to 20/800) at the Pre-operative Visit;
•Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography (FA) or OCT;
•Have an Endothelial Cell Density (ECD) above 1800 cells per millimeter;
•Have central anterior chamber depth (ACD) \>2.5 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit;
•Agree to participate in post-operative visual training
•For the Implanted Eye:
•Have evidence of visually significant cataract at the Pre-operative Visit;
•Agree to undergo pre-operative assessment with low vision specialists (optometrist, occupational therapist or other professional with low vision experience) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment

Exclusion Criteria

•For Both Eyes:
•Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
•Have evidence of bilateral active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
•Have any of the following conditions at the Pre-operative Visit:
•Stargardt macular dystrophy;
•Diabetic retinopathy;
•Untreated retinal tears;
•Retinal vascular disease;
•Optic nerve disease;
•History of retinal detachment;