The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD).
Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.
Be 55 years of age or older.
Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.
Have evidence of cataract.
Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.
Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP>22 mm Hg.
Corneal guttata.
Single group
SING IMT(TM) System, model NG SI IMT 3X
DeviceThe SING IMT 3X implant is a visual prosthetic implantable device, which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with bilateral, end-stage age-related macular degeneration.
Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system
The percent decrease in endothelial cell density (ECD).
Incision size needed for device implantation
Incision size will not exceed 8.0 mm (non-inferiority assumption) in 75% of surgeries
Surgical complications
AEs and serious adverse events
Improvement in near and distance best corrected visual acuity (BCVA) in implanted eyes.
Near and distance BCVA will show an improvement of ≥2 lines in the ETDRS chart in at least 50% (non-inferior to 50%) of the implanted eyes at 12 months post implantation.
Usability of SING IMT System, including delivery system
Surgeon will complete a usability and satisfaction questionnaire
Device stability and fixation
Assessed by slit lamp biomicroscopy examination: device tilt and device decentration
Post-operative anterior chamber depth (ACD)
Anterior Chamber Depth (ACD) evaluated by ultrasound biomicroscopy (UBM), ocular coherence tomography (OCT) or another applicable test method
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