Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost
NCT ID: NCT01443988
Last Updated: 2017-12-18
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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COMPLETED
PHASE4
101 participants
INTERVENTIONAL
2011-09-30
2017-04-30
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
NONE
Study Groups
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iStent
Implantation of two iStent devices
iStent
Implantation of two iStent devices
Drug
Travoprost drops
Travoprost
Travoprost drops
Interventions
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iStent
Implantation of two iStent devices
Travoprost
Travoprost drops
Eligibility Criteria
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Inclusion Criteria
* IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening)
Exclusion Criteria
* Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma
18 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Lilit A Voskanyan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
S.V. Malayan Ophthalmological Center, Yerevan, Armenia
Locations
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S.V. Malayan Ophthalmological Center
Yerevan, , Armenia
Countries
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References
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Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, Ahmed II, Saheb H. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmol Ther. 2016 Dec;5(2):161-172. doi: 10.1007/s40123-016-0065-3. Epub 2016 Sep 12.
Other Identifiers
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GCF-022
Identifier Type: -
Identifier Source: org_study_id
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