Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

Glaukos Corporation119 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

119

Conditions

Primary Open Angle Glaucoma (POAG)

Interventions

iStentDEVICE

Implantation of One iStent through a small temporal clear corneal incision.

iStentDEVICE

Implantation of Two iStents through a small temporal clear corneal incision

iStentDEVICE

Implantation of Three iStents through a small temperal 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 two topical hypotensive medications 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

Mean diurnal IOP <18 mmHg at month 12

Time frame: 12 months

Data from ClinicalTrials.gov

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