Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
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About
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.
Full description
The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. This is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the GTS400. Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery (Group 1, Investigational Group), or cataract surgery only (Group 2, Control Group). Clinical data through 12 months postoperative will form the basis of a pre-market approval (PMA) submission. Subjects will be followed for two years postoperatively.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
62 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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