Trials / Completed
CompletedNCT01818115
Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Ivantis, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Primary Open Angle Glaucoma
- Glaucoma, Open Angle, Pseudo-exfoliative
- Cataract Unilateral Pending Extraction
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hydrus Implant | |
| PROCEDURE | IOL placement |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2015-08-01
- Completion
- 2015-11-01
- First posted
- 2013-03-26
- Last updated
- 2019-02-04
Locations
7 sites across 4 countries: Germany, Italy, Netherlands, Spain
Source: ClinicalTrials.gov record NCT01818115. Inclusion in this directory is not an endorsement.