A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.

Official Title
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A Prospective, Randomized, Multi-Center, Open-Label Trial Comparing a Novel Goniotomy Procedure and an Ab Interno Trabecular Bypass Device in the Treatment of Mild to Moderate Glaucoma in Patients Undergoing Cataract Extraction

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Procedure: Goniotomy
* Device: Trabecular Micro-Bypass Stent
* Procedure: Cataract Extraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of open angle glaucoma (including pseudoexfoliation and pigmentary glaucoma) Diagnosis of mild to moderate glaucoma as defined by ICD-9 staging definitions 365.71 Mild/365.72 Moderate (including visual field defects and/or characteristic optic nerve abnormalities consistent with mild to moderate glaucoma) Planned removal of a visually significant cataract as determined by the Investigator (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction Exclusion Criteria: Any glaucoma diagnosis other than those noted in inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goniotomy<br>Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant. | Procedure: Goniotomy<br>* Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.<br>Procedure: Cataract Extraction<br>* Cataract extraction via Phaco and PCIOL implant.<br>|
| Active Comparator: Trabecular Micro-Bypass Stent<br>Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant. | Device: Trabecular Micro-Bypass Stent<br>* Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.<br>Procedure: Cataract Extraction<br>* Cataract extraction via Phaco and PCIOL implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in mean IOP |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, glaucoma surgery, ab interno