Age-Related Macular Degeneration Clinical Trial
Official title:
A Study of the Implantable Miniature Telescope, Model SING (SING IMT) in Patients With Central Vision Impairment Associated With End-stage Age Related Macular Degeneration in an Israeli Cohort
The objective of this single center study is to determine the safety of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in a small sample of patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD) in an Israeli Cohort
The SING IMT has CE Mark in the EU and has been implanted in over 200 patients globally including a pivotal study in the U.S. currently underway (the Concerto Study) and a post-marketing study in EU (The PMCF Study). Model SING is a new injectable model based on the IMT parent model (PMA P050034). 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 refraction, and also when using an external telescope simulator to determine if they are likely to benefit from receiving the SING IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery in one eye. 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 10 rehabilitation/training visits with a low vision specialist to learn how to use the fellow eye for ambulation and the eye with the implant for magnified viewing during daily activities. ;
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