Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorVisionCare, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Be 55 years of age or older.

Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.

Have evidence of cataract.

Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.

Disqualifiers

Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.

Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.

A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP>22 mm Hg.

Corneal guttata.

Trial design

Treatments tested in this trial

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

Treatment groups

76 Participants
are divided into 1 treatment group

Sponsors and collaborators