Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.

Study Overview
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Brief Summary
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The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.

Detailed Description
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This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals.

Official Title
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A Prospective, Multi-Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery.

Conditions
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Primary Open Angle Glaucoma, Glaucoma, Open Angle, Pseudo-exfoliative, Cataract Unilateral Pending Extraction

Intervention / Treatment
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* Device: Hydrus Implant
* Procedure: IOL placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma. Operable, age-related cataract eligible for phacoemulsification. Exclusion Criteria: Closed Angle and narrow angle forms of Glaucoma. Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: IOL placement with Hydrus Implant<br>Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant | Device: Hydrus Implant<br> <br> |
| Active Comparator: IOL placement only.<br>Cataract Extraction with IOL placement only. | Procedure: IOL placement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications. | The 24 month diurnal IOP will be compared to the baseline value and a % change will be determined for each subject. A 20% drop in diurnal IOP is a successful response to treatment. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mean washed out IOP at 24 months | The mean diurnal IOP for each subject will be calculated and the sorted by group. The group average IOP will be compared to in-group baseline and between groups at the follow up time point. | 24 months | 
| Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart. | A 24 month visit will be conducted to confirm 12 month findings. | 12 months | 
| The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout. | A 24 month visit will be conducted to confirm 12 month findings. | 12 months | 
| Diurnal IOP at 12 months following washout | A 24 month visit will be conducted to confirm 12 month findings | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POAG, PXG, IOL Surgery, CE Surgery