Trials / Completed
CompletedNCT02024464
Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery
A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 306 (actual)
- Sponsor
- Ivantis, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.
Detailed description
This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hydrus Microstent | Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber. |
| DEVICE | iStent Trabecular Micro Bypass | Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber. |
| PROCEDURE | Cataract removal and intraocular lens (IOL) implantation | Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2017-03-01
- Completion
- 2018-08-01
- First posted
- 2013-12-31
- Last updated
- 2024-07-03
- Results posted
- 2024-06-21
Source: ClinicalTrials.gov record NCT02024464. Inclusion in this directory is not an endorsement.