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

Glaukos Corporation79 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open-Angle Glaucoma

Interventions

iStent and iStent supraDEVICE

Implantation of two iStent devices and one iStent supra device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

S.V. Malayan Ophthalmological Center

Yerevan, Armenia

Outcomes

Primary Outcomes

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

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

Time frame: 12 Months

Secondary Outcomes

Mean diurnal IOP < 18mm Hg

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

Time frame: 12 months

Data from ClinicalTrials.gov

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