Study Results
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View full resultsBasic Information
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TERMINATED
NA
79 participants
INTERVENTIONAL
2017-10-12
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CyPass System
CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
CyPass Micro-Stent implanted with CyPass 241-S applier
CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.
Cataract surgery
Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit
Interventions
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CyPass Micro-Stent implanted with CyPass 241-S applier
CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.
Cataract surgery
Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of primary open angle glaucoma (POAG)
* Medicated intraocular pressure (IOP) of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg
* An operable age-related cataract eligible for phacoemulsification
* Visual acuity as specified in the protocol
Exclusion Criteria
* Use of ocular hypotensive medication/s, as specified in the protocol
* Diagnosis of glaucoma other than POAG, as specified in the protocol
* Other medical conditions, as specified in the protocol
* Proliferative diabetic retinopathy
* Previous surgery for retinal detachment
* Previous corneal surgery
* Wet age-related macular degeneration
* Poor vision in the non-study eye not due to cataract
* Significant ocular inflammation or infection within 30 days of screening visit
* Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits
* Women who are pregnant or nursing
45 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Clinical Trial Lead, Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Alcon Investigative Site
Phoenix, Arizona, United States
Alcon Investigative Site
Orange, California, United States
Alcon Investigative Site
Fort Collins, Colorado, United States
Alcon Investigative Site
Jacksonville, Florida, United States
Alcon Investigative Site
Panama City, Florida, United States
Alcon Investigative Site
Gainesville, Georgia, United States
Alcon Investigative Site
Marietta, Georgia, United States
Alcon Investigative Site
Garden City, Kansas, United States
Alcon Investigative Site
Fraser, Michigan, United States
Alcon Investigative Site
St Louis, Missouri, United States
Alcon Investivative Site
St Louis, Missouri, United States
Alcon Investigative Site
Vineland, New Jersey, United States
Alcon Investigative Site
Bala-Cynwyd, Pennsylvania, United States
Alcon Investigative Site
Chambersburg, Pennsylvania, United States
Alcon Investigative Site
Austin, Texas, United States
Alcon Investigative Site
El Paso, Texas, United States
Alcon Investigative Site
Houston, Texas, United States
Alcon Investigative Site
Bellevue, Washington, United States
Alcon Investigative Site
Kenosha, Wisconsin, United States
Alcon Investigative Site
Racine, Wisconsin, 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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GLD122c-C001
Identifier Type: -
Identifier Source: org_study_id
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