Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy
NCT ID: NCT04440527
Last Updated: 2020-06-19
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
NA
70 participants
INTERVENTIONAL
2020-07-22
2024-07-22
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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Microshunt
Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).
Preserflo / Innfocus Microshunt
The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.
Trabeculectomy
Patients will be treated with trabeculectomy.
Trabeculectomy
Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
Interventions
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Preserflo / Innfocus Microshunt
The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.
Trabeculectomy
Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
Eligibility Criteria
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Inclusion Criteria
* Primary open angle glaucoma or pseudoexfoliation glaucoma
* medically uncontrollable intraocular pressure or intolerance of topical therapy
* negative urine/serum pregnancy test of women in childbearing age
* signed and dated informed consent
Exclusion Criteria
* pregnancy, nursing period
* Patients in military service, training periods and civil service
* Participation in another clinical trail
* pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva
18 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Locations
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Medical University Innsbruck
Innsbruck, Tyrol, Austria
Countries
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Central Contacts
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Other Identifiers
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PAINT-Study
Identifier Type: -
Identifier Source: org_study_id
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