A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent

Glaukos Corporation80 enrolled

Overview

The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Subject With Primary Open-angle Glaucoma (POAG)

Interventions

iStent Supra StentDEVICE

Implantation of one iStent Supra Stent 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. Malayan Ophthalmology Centre

Yerevan, Armenia

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Mean diurnal Intraocular Pressure < 18 mmHg at month 12

Time frame: 12 months

Data from ClinicalTrials.gov

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