Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG

Ivantis, Inc.120 enrolled

Overview

The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.

This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens. Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus. Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Primary Open Angle Glaucoma

Interventions

prestudy topical glaucoma medicationsDRUG

Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Elevated intraocular pressure (IOP) * Diagnosis of mild to advanced open-angle glaucoma * Shaffer Grade III * Mental capacity to cooperate when undergoing operative and postoperative examination * 18 years of age or older * Provide written informed consent * Willing and able to return to scheduled follow-up examinations for 24-months Exclusion Criteria: * Closed-angle and narrow-angle forms of glaucoma * Secondary glaucomas * Congenital or developmental glaucoma

Locations (5)

University Medical Center Vienna

Vienna, Austria

Aurelios Augenzentrum

Recklinghausen, Erlbruch, Germany

Unnamed facility

Berlin, Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik

Mainz, Germany

Outcomes

Primary Outcomes

Change in IOP of study eye between each randomized group

Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit.

Time frame: Baseline & One year

Secondary Outcomes

Change in glaucoma medications

Calculate the change in the number of glaucoma medications from baseline (pre-operative) visit to the 12-month post-operative visit.

Time frame: Baseline & One year

Data from ClinicalTrials.gov

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