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

Primary Open Angle Glaucoma Clinical Trial

Official title:
A Prospective, Multi-Center Evaluation of the Hydrus Aqueous Implant (Standard and Low-Profile) for Lowering Intraocular Pressure (IOP) in Subjects With Mild to Advanced Primary Open Angle Glaucoma (POAG) With or Without a Cataract

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03065036
Study type Interventional
Source Ivantis, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2010
Completion date February 2014
View Details
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