NCT05438732

Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD

A Prospective, Multicenter Clinical Study of the Implantable Miniature Telescope, Model SING in Patients with Central Vision Impairment Associated with End-stage Age-related Macular Degeneration (AMD)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: VisionCare, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).

Detailed description

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 and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. 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 12 rehabilitation/training visits with a low vision specialist

Conditions

• Age-Related Macular Degeneration
• Geographic Atrophy

Interventions

Type	Name	Description
DEVICE	smaller incision, new generation implantable miniature telescope (SING-IMT)	The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)

Timeline

• Start date: 2022-06-16
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-06-30
• Last updated: 2024-12-03

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study