Post-Approval Study of the Implantable Miniature Telescope

Launched by VISIONCARE, INC. · Dec 20, 2012

Keywords

ClinConnect Summary

ECD sub-study. At investigative sites participating in the ECD Sub-Group study, corneal endothelial cell density will be measured by non-contact specular microscopy in a subgroup of 150 patients enrolled in the IMT-PAS-01 in the eye schedule for and implanted with the intraocular telescope at study entry, 3 months, 12, months, 24 months, 36 months, 48 months and 60 months.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Stargardt's macular dystrophy
• • Anterior chamber depth \< 3.0mm
• • Presence of corneal guttate
• • Do not meet minimum age and endothelial cell density requirements
• • evidence of CNV or treatment of CNV within the past 6 months
• • cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
• • 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
• • history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP \>22 mm Hg while on maximum medication
• • known sensitivity to post-operative medications
• • history of eye rubbing or an ocular condition that predisposes eye rubbing
• • myopia \>6.0 D
• • hyperopia \>4.0D
• • axial length \<21mm
• • narrow angle, i.e., \<Schaffer grade 2
• • cornea stromal or endothelian dystrophies, including guttate
• • inflammatory ocular disease
• • zonular weakness/instability of crystalline lens, or pseudoexfoliation
• • diabetic retinopathy
• • untreated retinal tears
• • retinal vascular disease
• • optic nerve disease
• • history of retinal detachment
• • intraocular tumor
• • retinitis pigmentosa