Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
38 participants
OBSERVATIONAL
2023-04-01
2024-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Open Angle Glaucoma
Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation.
Hydrus Microstent
Hydrus Microstent placed at the time of cataract surgery
Interventions
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Hydrus Microstent
Hydrus Microstent placed at the time of cataract surgery
Eligibility Criteria
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Inclusion Criteria
* Current treatment with one or more ocular hypotensive medication
* Corneal thickness between 470 to 610µm
* Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively
Exclusion Criteria
* corneal opacity or angle abnormalities that make visualizing the angle difficult
* Past ocular surgery
* History of ocular, systemic medications, or systemic diseases/co-morbidities that significantly impact on quality of life or vision (e.g. advanced macular degeneration, autoimmune diseases, mental illness/depression, uncontrolled systemic disease on polypharmacy)
* Severe dry eye requiring secretagogues, serum eyedrops, topical corticosteroids, amniotic membrane grafts
18 Years
ALL
Yes
Sponsors
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InSight Vision Center Medical Group, Inc
OTHER
Responsible Party
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Eric Poulsen
Ophthalmologist
Locations
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Terri Smith
Fresno, California, United States
Countries
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Central Contacts
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Facility Contacts
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Terri Smith
Role: primary
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HQoL-23
Identifier Type: -
Identifier Source: org_study_id
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