International Study of the SING IMT Prosthesis in Patients 55 and Older With Advanced Age-Related Macular Degeneration and Bilateral Central Vision Loss

What this Trial Is About

Researchers are evaluating the SING IMT prosthesis in patients aged 55 and older who have pseudophakic eyes eyes with implanted intraocular lenses and suffer from late-stage Age-Related Macular Degeneration AMD with moderate to profound bilateral central vision impairment. This international, randomized, multicenter study aims to expand the devices approved use and assess its safety and effectiveness in this specific patient group. The findings will support regulatory decisions, help clinical care, and may lead to label expansion for the device. The study involves two treatment approaches one where the SING IMT device replaces the existing intraocular lens IOL after removal Lens Exchange group, and another where the device is implanted in front of the existing IOL without removal Add-On group. Both procedures place the device in the sulcus area of the eye. Participants will be randomly assigned to one of these two groups. The trial includes multiple follow-up periods to assess outcomes after implantation. Participants will undergo vision tests and eye examinations at the start and then at 1, 3, and 6 months after the procedure. Key assessments include measuring the percentage of endothelial cell density ECD loss, visual acuity, and recording any surgical complications or adverse events. Patient-reported outcomes and the size of the incision needed for implantation will also be tracked. Participants are expected to engage in a postoperative training program for using the implant. The total study duration for each participant covers these assessments and monitoring visits.

International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study