AMD
Conditions
Brief summary
The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level). The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.
Detailed description
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.
Interventions
DEVICEImplantable Miniature Telescope
Device - Implantable Miniature Telescope
Sponsors
VisionCare, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long term safety study of implantable miniature telescope | 5 years after implantation | Number of persistent vision impairing corneal edema adverse events |
Countries
United States
Outcome results
None listed