A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Open Angle Glaucoma
- Sponsor
- Ivantis, Inc.
- Enrollment
- 306
- Primary Endpoint
- Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
- •An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.
Exclusion Criteria
- •Forms of primary or secondary glaucoma not listed above
- •Prior glaucoma surgery in the study eye
Outcomes
Primary Outcomes
Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12
Time Frame: Month 12: 8 am, 12 pm, 4 pm
Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.
Secondary Outcomes
- Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12(Month 12: 8 am, 12 pm, and 4 pm)
- Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12(Month 12: 8 am, 12 pm, 4 pm)