A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents and a Postoperative Prostaglandin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Open-Angle Glaucoma
- Sponsor
- Glaukos Corporation
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
- •Open-angle glaucoma (including pseudoexfoliative)
Exclusion Criteria
- •Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
- •Prior ALT
- •Prior SLT within 90 days of screening visit
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Mean diurnal IOP < 18mm Hg(12 months)