A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra

Glaukos Corporation7 enrolled

Overview

Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma, Open-Angle

Interventions

G2 and G3DEVICE

Two iStent inject devices and one iStent supra device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg Exclusion Criteria: * Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200

Locations (1)

Prof. Dr. med. Carl Erb

Berlin, Germany

Outcomes

Primary Outcomes

20% IOP reduction

IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg

Time frame: Month 12

Secondary Outcomes

IOP less than or equal to 18 mm Hg

IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg

Time frame: Month 12

Data from ClinicalTrials.gov

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