Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

Glaukos Corporation40 enrolled

Overview

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Subjects With Primary Open-angle Glaucoma (POAG)

Interventions

iStentDEVICE

Implantation of two iStents through a small temporal clear corneal incision

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with primary open-angle glaucoma (POAG) * Subject on one topical hypotensive medication Exclusion Criteria: * Traumatic, uveitic, neovascular, or angle closure glaucoma * Fellow eye already enrolled

Locations (1)

S.V. Malayan's Ophthalmology Centre

Yerevan, Armenia

Outcomes

Primary Outcomes

Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline

Time frame: 12 Months

Secondary Outcomes

IOP < 18 mm Hg at Month 12

Time frame: 12 months

Data from ClinicalTrials.gov

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