Phase 3
N=44
Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
Open-angle Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00721968 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications — 18; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Glaucoma Stent Surgery (GTS400 Stent) (Device); cataract surgery alone (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Glaukos Corporation
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications |
18; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery
- Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form
Exclusion Criteria
Not meeting inclusion criteria
Data sourced from ClinicalTrials.gov (NCT00721968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.