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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable Miniature Telescope | Other | Post approval study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Miniature Telescope | Device | Device - Implantable Miniature Telescope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long term safety study of implantable miniature telescope | Number of persistent vision impairing corneal edema adverse events | 5 years after implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver D Schein, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85225 | United States | ||
| Retinal Consultants of Arizona, LTD |
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| Phoenix |
| Arizona |
| 85014 |
| United States |
| Barnet, Dulaney, Perkins Eye | Phoenix | Arizona | 85016 | United States |
| Retina-Vitreous Associates | Beverly Hills | California | 90211 | United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Loma Linda University Health Care | Loma Linda | California | 92350 | United States |
| University of California - Davis | Sacramento | California | 95817 | United States |
| Specialty Eye Care (Glaucoma Consultants of Colorado) | Parker | Colorado | 80134 | United States |
| Retina Speciality Institute | Pensacola | Florida | 32503 | United States |
| Sarasota Retinal Institute | Sarasota | Florida | 34239 | United States |
| Emory Eye Center | Atlanta | Georgia | 30322 | United States |
| University of Michigan, Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Pepose Vision Institute | Chesterfield | Missouri | 63017 | United States |
| New York Eye & Ear | New York | New York | 10003 | United States |
| Fine, Hoffman & Packer | Eugene | Oregon | 97401 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |