NCT02023242
Completed
Not Applicable
A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Open Angle Glaucoma
- Sponsor
- Ivantis, Inc.
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Unmedicated IOP </= 19 mmHg at 12 Months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
- •A phakic lens with BCVA of 20/30 or better
Exclusion Criteria
- •Forms of primary or secondary glaucoma not listed above
- •Prior glaucoma surgery in the study eye
Outcomes
Primary Outcomes
Unmedicated IOP </= 19 mmHg at 12 Months
Time Frame: 12 months
Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 12 months
Secondary Outcomes
- Unmedicated IOP </= 19 mmHg at 24 Months(24 Months)
- Unmedicated IOP </= 18 mmHg at 12 Months(12 months)
- The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months(12 & 24 Months)
- Mean Medication Use at 12 and 24 Months(12 & 24 Months)
Study Sites (1)
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