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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Primary Open Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: prestudy topical glaucoma medications


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrus Aqueous Implant<br>Hydrus implanted into Schlemm's Canal. | Drug: prestudy topical glaucoma medications<br>* Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.<br>|
| Other: IOL placement and Hydrus implant<br>Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal | Drug: prestudy topical glaucoma medications<br>* Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline & One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline & One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Open Angle Glaucoma, POAG