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

Not Applicable

Completed

• Conditions: Open-Angle Glaucoma
• Interventions: Device: iStent and iStent supra

• Registration Number: NCT01456390
• Lead Sponsor: Glaukos Corporation

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iStent and iStent supra	iStent and iStent supra	Implantation of two iStent devices and one iStent supra device

Primary Outcome Measures

Name	Time	Method
Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP	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 Outcome Measures

Name	Time	Method
Mean diurnal IOP < 18mm Hg	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

Trial Locations

Locations (1)

S.V. Malayan Ophthalmological Center; 🇦🇲 Yerevan, Armenia