Hydrus Microstent for Refractory Open-Angle Glaucoma

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.

Detailed Description
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Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.

Official Title
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The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)

Conditions
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Open-angle Glaucoma

Intervention / Treatment
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* Device: Hydrus Microstent
* Procedure: Ophthalmic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open-angle glaucoma with optic nerve pathology; Best Corrected Visual Acuity of 20/80 or better in study eye; Refractory glaucoma; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma; Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma; Pre-perimetric glaucoma; Ocular hypertension Shallow or flat anterior chamber; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 45 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrus Microstent<br>Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted. | Device: Hydrus Microstent<br>* Device implanted into the Schlemm's canal of the eye for the purpose of providing a natural outflow pathway for aqueous humor. The Hydrus Microstent is intended for lifetime use of the glaucoma patient.<br>Procedure: Ophthalmic surgery<br>* Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline | IOP will be measured using Goldmann Applanation tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve MDIOP. | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in MDIOP at Month 12 | IOP will be measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve MDIOP. | Baseline, Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma