Trials / Completed
CompletedNCT02023242
Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- Ivantis, Inc. · Industry
- Sex
- All
- Age
- 45 Years – 84 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
Detailed description
This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. 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. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2017-08-01
- Completion
- 2018-01-01
- First posted
- 2013-12-30
- Last updated
- 2019-12-10
- Results posted
- 2019-12-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02023242. Inclusion in this directory is not an endorsement.