Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

Glaukos Corporation79 enrolled

Overview

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Open-angle Glaucoma

Interventions

One iStentDEVICE

Implantation of one iStent in conjunction with cataract surgery

Two iStentDEVICE

Implantation of two iStent in conjunction with cataract surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation * Primary open-angle glaucoma (including pigmentary or pseudoexfoliative) Exclusion Criteria: * Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye) * Prior stent implantations (study eye)

Locations (1)

S.V. Malayan Ophthalmological Center

Yerevan, Armenia

Outcomes

Primary Outcomes

Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP

Time frame: 12 Months

Data from ClinicalTrials.gov

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