Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost

Glaukos Corporation101 enrolled

Overview

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Open-angle Glaucoma

Interventions

iStentDEVICE

Implantation of two iStent devices

TravoprostDRUG

Travoprost drops

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Phakic study eye * IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening) Exclusion Criteria: * Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs) * Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Locations (1)

S.V. Malayan Ophthalmological Center

Yerevan, Armenia

Outcomes

Primary Outcomes

Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.

Time frame: 12 months

Data from ClinicalTrials.gov

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