Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent
NCT ID: NCT04629521
Last Updated: 2024-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2020-12-21
2023-04-05
Brief Summary
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Detailed Description
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The COMPASS XT Trial (TMI-09-01E/GLD122b-C001/NCT02700984) was designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data was collected at 36 months, 48 months, and 60 months postoperatively for a total of 5-year follow-up across the 2 studies.
In this trial, COMPASS XXT, clinical data will be collected annually for the subjects who were implanted with the CyPass Micro-Stent in the COMPASS TRIAL until the subject reaches 10 years post-CyPass implantation. For some subjects, the first visit will be at or after 10 years post-CyPass implantation, and therefore the first visit may coincide with the Exit visit.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Cataract Surgery + CyPass
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
CyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.
Cataract Surgery
Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
Interventions
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CyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.
Cataract Surgery
Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits.
Exclusion Criteria
45 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Operations Lead, Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Eye Physicians and Surgeons of Arizona
Glendale, Arizona, United States
Coastal Vision Medical Group
Orange, California, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States
Cape Coral Eye Center
Cape Coral, Florida, United States
Jones Eye Center PC
Sioux City, Iowa, United States
Ophthalmology Associates
St Louis, Missouri, United States
Eye Associates and SurgiCenter of Vineland
Vineland, New Jersey, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Associates In Ophthalmology Ltd.
West Mifflin, Pennsylvania, United States
University Eye Specialists
Maryville, Tennessee, United States
The Vanderbilt Eye Institute
Nashville, Tennessee, United States
Ophthalmology Associates
Fort Worth, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GLD122-P004
Identifier Type: -
Identifier Source: org_study_id
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