NCT04796545

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

A Prospective, Multicenter Post-marketing Clinical Investigation of the SING IMT(TM) System, Model NG SI IMT 3X in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: VisionCare, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an interventional, prospective, multicenter, open label, single group assignment Post-Market Clinical Follow-up (PMCF) study in men and women \>=55 years with central vision impairment associated with end-stage AMD. Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study. Baseline visual acuity of the study subjects will be assessed with a 2.8X external telescope simulator (ETS) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts to determine if they are likely to benefit from receiving the IMT. To be included in the study and to proceed with the surgery, subjects must achieve, using the ETS, at least a one line (5 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery. Subjects not meeting these criteria will be excluded from the study. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Postoperatively, the surgeon will complete a usability and satisfaction questionnaire after each implantation procedure. The patients will undergo ophthalmic evaluations in both eyes at regular intervals for up to 12 months. The subjects will also be required to undergo 6 to 10 additional visits for vision training with a low vision specialist. Surgical complications, as well as all Adverse Event (AEs) and use of medications will be monitored from baseline to the end of the study.

Conditions

• AMD
• Age-Related Macular Degeneration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-13
• Primary completion: 2027-02-01
• Completion: 2028-12-01
• First posted: 2021-03-15
• Last updated: 2026-02-10

Locations

13 sites across 7 countries: Belgium, France, Germany, Ireland, Italy, Spain, United Kingdom