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%.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
770
Device - Implantable Miniature Telescope
Arizona Eye Center
Chandler, Arizona, United States
Retinal Consultants of Arizona, LTD
Phoenix, Arizona, United States
Barnet, Dulaney, Perkins Eye
Phoenix, Arizona, United States
Retina-Vitreous Associates
Beverly Hills, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Loma Linda University Health Care
Loma Linda, California, United States
University of California - Davis
Sacramento, California, United States
Specialty Eye Care (Glaucoma Consultants of Colorado)
Parker, Colorado, United States
Retina Speciality Institute
Pensacola, Florida, United States
Sarasota Retinal Institute
Sarasota, Florida, United States
...and 6 more locations
Long term safety study of implantable miniature telescope
Number of persistent vision impairing corneal edema adverse events
Time frame: 5 years after implantation
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