Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

Conditions
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Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Dispersion Glaucoma

Intervention / Treatment
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* Device: Hydrus Microstent
* Device: iStent Trabecular Micro Bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrus Microstent<br>Patients randomized to the Hydrus Microstent | Device: Hydrus Microstent<br>* Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.<br>|
| Active Comparator: iStent Trabecular Micro Bypass<br>Patients randomized to the iStent Trabecular Micro Bypass | Device: iStent Trabecular Micro Bypass<br>* Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure at Month 12 | The primary effectiveness endpoint for this study is IOP at 12 months following surgery. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients requiring supplemental medication. | The proportion of patients requiring supplemental medication for pressure control. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary dispersion glaucoma, PDG, Hydrus