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Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery. — Hydrus II  

Primary Open Angle Glaucoma Clinical Trial

Official title:
A Prospective, Multi-Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery.

Clinical Trial Summary

The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.

Clinical Trial Description

This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01818115
Study type Interventional
Source Ivantis, Inc.
Contact
Status Completed
Phase N/A
Start date January 2011
Completion date November 2015
View Details
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