Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma

Study Overview
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Brief Summary
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The goal of the study is to prospectively evaluate and compare Hydrus microstent to the iStent Inject Wide in combination with cataract surgery in patients with mild to moderate open angle glaucoma. Hydrus and iStent are the two FDA approved trabecular meshwork targeting microstents to treat open angle glaucoma in conjunction with cataract surgery.

Official Title
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Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Device: Combined cataract surgery with Hydrus microstent
* Device: Combined cataract surgery with iStent Inject W


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >60 years or older Visually significant cataract Mild to moderate primary open angle glaucoma controlled on medications undergoing cataract surgery with lens implantation and concurrent microstent placement IOP ≥ 21 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s) CCT 480 to 620μm No prior ocular surgery including corneal refractive surgery No SLT within 6 months of baseline visit, no history of intracameral glaucoma drug eluting implants Visual field mean deviation ≤ -12 dB Optic nerve abnormalities consistent with glaucoma, C/D ratio less than ≤0.8 Exclusion Criteria: Prior intraocular surgery Visual field MD ≥ -12 dB secondary glaucoma including uveitis, traumatic, malignant, neovascular, and congenital glaucoma. Glaucoma related to elevated episcleral venous pressure including Sturge-Weber syndrome, thyroid eye disease, orbital tumor, and etc. Uncontrolled intraocular pressure on maximum tolerated medical therapy; Unable to perform wash-out IOP Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities including angle closure glaucoma Corneal disease or dystrophy Pathological myopia with degeneration that affects diagnostic imaging Clinically significant ocular pathology or degenerative diseases that affect vision, visual field, or optical coherence tomography of optic nerve. Inability to perform reliable Visual Field and optical coherence tomography.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Combined cataract surgery with Hydrus microstent<br> | Device: Combined cataract surgery with Hydrus microstent<br>* Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.<br>Device: Combined cataract surgery with iStent Inject W<br>* Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.<br>|
| Active Comparator: Combined cataract surgery with iStent Inject W<br> | Device: Combined cataract surgery with Hydrus microstent<br>* Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.<br>Device: Combined cataract surgery with iStent Inject W<br>* Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with complete success defined as intraocular pressure reduction > 25% from baseline And without secondary intervention to reduce IOP (medication, laser trabeculoplasty, or surgery) at 24 month. |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative and postoperative adverse events rates |  | 24 Months | 
| Rates of secondary intervention to reduce intraocular pressure |  | 24 Months | 
| Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure |  | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MIGS, Primary Open Angle Glaucoma, Hydrus, iStent, minimally invasive glaucoma surgery, randomized