Clinical Trial: Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass S

Brief Summary: Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Detailed Summary: Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.
Sponsor: Glaukos Corporation

Current Primary Outcome: Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP [ Time Frame: 12 Months ]

Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit


Original Primary Outcome: Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP [ Time Frame: 12 Months ]

Current Secondary Outcome: Mean diurnal IOP < 18mm Hg [ Time Frame: 12 months ]

Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP < 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 visit


Original Secondary Outcome:

Information By: Glaukos Corporation

Dates:
Date Received: September 28, 2011
Date Started: September 2011
Date Completion: April 2017
Last Updated: May 18, 2015
Last Verified: May 2015