Clinical Study of the Smaller Incision Implantable Miniature Telescope SING-IMT for Patients 65 and Older with Late-stage Age-related Macular Degeneration and Central Vision Loss

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the smaller incision, new generation implantable miniature telescope SING-IMT in patients aged 65 and older who have moderate to severe central vision loss caused by late-stage age-related macular degeneration AMD. The study focuses on individuals with vision impairment due to geographic atrophy or disciform scars affecting the central retina, conditions related to advanced AMD. Participants who qualify will undergo implantation of the SING-IMT device during routine cataract surgery. The device consists of two micro lenses within a glass tube mounted on a flexible silicone carrier and is inserted through an approximately 6.5 mm incision using a proprietary delivery system. After implantation, patients will attend five follow-up visits over about 12 months and may receive up to 12 rehabilitation or training sessions with a low vision specialist to help adapt to the device. Throughout the study, participants will have their best-corrected distance and near visual acuity checked, including tests with and without refraction and with an external telescope simulator to assess potential benefit. Researchers will monitor safety and effectiveness outcomes approximately 12 months post-surgery, including measurements of visual acuity, anterior chamber depth, device positioning, adverse events, and posterior capsule opacification. The total study involvement lasts about one year following surgery, with ongoing assessments and rehabilitation support.

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