Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

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.

Inclusion Criteria:

• mild to moderate primary open-angle glaucoma
• currently treated with ocular hypotensive medication
• pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
• subject scheduled to undergo cataract surgery

Exclusion Criteria:

• primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
• retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure