Post-Approval Study of the Implantable Miniature Telescope
Public ClinicalTrials.gov record NCT01757132. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Post-approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients With Bilateral Severe to Profound Central Vision Impairment Assoc. With End-stage Age-related Macular Degeneration
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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%.
Study identification
- NCT ID
- NCT01757132
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 770 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2010
- Primary completion
- Nov 30, 2023
- Completion
- Nov 30, 2028
- Last update posted
- Nov 15, 2018
2010 – 2028
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85225 | — |
| Retinal Consultants of Arizona, LTD | Phoenix | Arizona | 85014 | — |
| Barnet, Dulaney, Perkins Eye | Phoenix | Arizona | 85016 | — |
| Retina-Vitreous Associates | Beverly Hills | California | 90211 | — |
| Retina Consultants of Orange County | Fullerton | California | 92835 | — |
| Loma Linda University Health Care | Loma Linda | California | 92350 | — |
| University of California - Davis | Sacramento | California | 95817 | — |
| Specialty Eye Care (Glaucoma Consultants of Colorado) | Parker | Colorado | 80134 | — |
| Retina Speciality Institute | Pensacola | Florida | 32503 | — |
| Sarasota Retinal Institute | Sarasota | Florida | 34239 | — |
| Emory Eye Center | Atlanta | Georgia | 30322 | — |
| University of Michigan, Kellogg Eye Center | Ann Arbor | Michigan | 48105 | — |
| Pepose Vision Institute | Chesterfield | Missouri | 63017 | — |
| New York Eye & Ear | New York | New York | 10003 | — |
| Fine, Hoffman & Packer | Eugene | Oregon | 97401 | — |
| Valley Retina Institute | McAllen | Texas | 78503 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01757132, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 15, 2018 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01757132 live on ClinicalTrials.gov.