Post-Approval Study of the Implantable Miniature Telescope

Prior treatment

• previous intraocular or cornea surgery of any kind in operative eye, including any type of surgery for either refractive or therapeutic purposes or who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
• known sensitivity to post-operative medications

Other illness

• cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
• history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP \>22 mm Hg while on maximum medication
• history of eye rubbing or an ocular condition that predisposes eye rubbing
• inflammatory ocular disease
• retinal vascular disease
• optic nerve disease
• history of retinal detachment

Age

• Do not meet minimum age and endothelial cell density requirements

Other

• Stargardt's macular dystrophy
• Anterior chamber depth \< 3.0mm
• Presence of corneal guttate
• evidence of CNV or treatment of CNV within the past 6 months
• myopia \>6.0 D
• hyperopia \>4.0D
• axial length \<21mm
• narrow angle, i.e., \<Schaffer grade 2
• cornea stromal or endothelian dystrophies, including guttate
• zonular weakness/instability of crystalline lens, or pseudoexfoliation
• diabetic retinopathy
• untreated retinal tears
• intraocular tumor
• retinitis pigmentosa

• stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
• 65 years of age or older
• retinal findings of geographic atrophy or disciform scar with foveal involvement
• visually significant cataract
• agree to undergo pre- and post-surgery training and assessment
• achieve at least a 5-letter improvement with external telescope
• have adequate peripheral vision in the eye not scheduled for surgery