Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
NCT ID: NCT02023242
Last Updated: 2019-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2012-10-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hydrus Microstent
Patients randomized to the Hydrus Microstent .
Hydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
iStent Trabecular Micro Bypass
Patients randomized to the iStent Trabecular Micro Bypass
iStent Trabecular Micro Bypass
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Interventions
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Hydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
iStent Trabecular Micro Bypass
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Eligibility Criteria
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Inclusion Criteria
* A phakic lens with BCVA of 20/30 or better
Exclusion Criteria
* Prior glaucoma surgery in the study eye
45 Years
84 Years
ALL
No
Sponsors
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Ivantis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Julian Garcia Feijoo, Prof. Med.
Role: PRINCIPAL_INVESTIGATOR
Madrid, Spain
Locations
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Contact Richard Hope at Ivantis
Irvine, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP-12-001
Identifier Type: -
Identifier Source: org_study_id
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