Baseline visual acuity of the study subjects will be assessed with a 2.7X external telescope simulator (ETS) using Early Treatment Diabetic Retinopathy Trial (ETDRS) charts. 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. Visual acuity must be at least one line (5 or more letters) better with the ETS than Best Corrected Visual Acuity (BCVA) in the fellow eye without the ETS. Subjects not meeting these criteria will be excluded from the study. Following this assessment, eligible subjects will undergo three pre-op visits with the low vision rehabilitation/training specialist prior to continuation of testing for inclusion in the study.~Once it will be determined that the subject experiences improvement in visual acuity with the use of the ETS, he/she will be further evaluated for eligibility, with near and distance BCVA, manifest refraction, intraocular pressure (IOP), slit lamp examination, non-contact specular microscopy (before or after home use of ETS), Anterior Chamber Depth (ACD) profile by Ultrasound Biomicroscopy (UBM), Optical Coherence Tomography (OCT), or another applicable test method, and axial eye length.~The participants will be implanted with the Tsert System model NG SI IMT 3X. 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 to determine the change in visual acuity and Endothelial Cell Density (ECD) in the both eyes. 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.
The NG SI IMT (Next Generation Small Incision Implantable Miniature Telescope) 3X implant is intended to improve vision in patients with end-stage Age-related Macular Degeneration (AMD).~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. After signing an informed consent, subjects will be prescreened for eligibility in the study.