Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes

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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma

Conditions
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Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary 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 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 84 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 |
| --- | --- | --- |
| Unmedicated IOP </= 19 mmHg at 12 Months | Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 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 | The mean medication use at 12 and 24 months | 12 & 24 Months | 
| Unmedicated IOP </= 19 mmHg at 24 Months | Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 24 months | 24 Months | 
| Unmedicated IOP </= 18 mmHg at 12 Months | Percentage of subjects with IOP </= 18 mmHg and without the use of ocular hypotensive medications at 12 months | 12 months | 

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