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)
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).
• Be at least 65 years of age at the Pre-operative Visit;
• Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;
• Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;
• Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:
‣ lack of need of treatment for CNV over the past 6 months, and
⁃ lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and
⁃ lack of Retinal hemorrhage on exam over a 6-month period or longer
• Agree to participate in post-operative visual training
• For the Implanted Eye:
• Have evidence of visually significant cataract at the Pre-operative Visit;
• Agree to undergo pre-operative training and assessment (1 or more sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment
• For the Non-Implanted Eye:
• Have adequate peripheral vision at the Pre-operative Visit to allow navigation