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

Glaukos Corporation39 enrolled

Overview

The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated 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

iStentsDEVICE

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) * Subjects on two topical hypotensive medications Exclusion Criteria: * Traumatic, uveitic, neovascular, or angle closure glaucoma * Fellow eye already enrolled

Locations (1)

S.V. Malayna'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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