Closed to Enrollment
A Prospective, Multicenter Post Approval Study of VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE (BY DR. ISAAC LIPSHITZ) in patients with bilateral severe to profound central vision impairment associated with End Stage Age Related Macular Degeneration. PROTOCOL IMT-PAS-01
- The intraocular telescope is indicated for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe (distance BCVA of 20/160 or poorer) to profound (distance BCVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
- Have retinal findings of geographic atrophy or disciform scar with foveal involvement, asdetermined by fluorescein angiography
- Have evidence of visually significant cataract (> Grade 2)
- Agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision.
- Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope