An interventional study of iStent inject and Cataract surgery in Primary Open-angle Glaucoma, sponsored by Glaukos Corporation. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by Glaukos Corporation · Not applicable, Interventional, and Treatment
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 505 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Glaukos Corporation is the lead sponsor of 67 studies on the registry; 14 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implantation of two GTS400 stents using G2-M-IS iStent inject
Device: iStent inject
Cataract surgery alone
Procedure: Cataract surgery
Implantation of two GTS400 stents using G2-M-IS iStent inject
Cataract surgery alone
≥ 20% Reduction in Intraocular Pressure (IOP)
Time frame: Baseline and Month 24
Diurnal IOP Reduction from Baseline
Time frame: Baseline and Month 24
Safety follow-up post-PMA to be through 36 months
Time frame: 36 months
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Glaukos Corporation