At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 62 enrolled
Drug / intervention
Glaucoma Stent Surgery (GTS400 Stent) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery
In Brief
A Phase 3 clinical trial evaluating Glaucoma Stent Surgery (GTS400 Stent) and cataract surgery alone for Open-angle Glaucoma. Completed, enrolled 62 participants.
Detailed Summary
To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpen-angle Glaucoma
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedJul 2008
Primary CompletionFeb 2012
Study CompletionAug 2012
TodayJul 2026
First PostedJul 25, 2008
Enrollment StartMar 1, 2007
Primary CompletionFeb 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.9 years ago
Interventions
Glaucoma Stent Surgery (GTS400 Stent)device
ab interno trabecular bypass stent surgery
cataract surgery aloneprocedure
Cataract surgery alone