An interventional study of iStent and Cataract surgery in Primary Open Angle Glaucoma, sponsored by Glaukos Corporation. Status unknown at 14 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2021-10-20.
Sponsored by Glaukos Corporation · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 360 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 one iStent in conjunction with cataract surgery
Device: iStent
Cataract surgery alone
Procedure: Cataract surgery
Implantation of one iStent in conjunction with cataract surgery
Also known as: GTS100
Cataract surgery alone
Rate of sight-threatening adverse events
Time frame: 36 months
Other adverse events
For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.
Time frame: 36 months
Diurnal IOP reduction ≥ 20%
Time frame: Baseline and 24 months
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Glaukos Corporation