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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Goniotomy

Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.

Group Type EXPERIMENTAL

Goniotomy

Intervention Type PROCEDURE

Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.

Cataract Extraction

Intervention Type PROCEDURE

Cataract extraction via Phaco and PCIOL implant.

Trabecular Micro-Bypass Stent

Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant.

Group Type ACTIVE_COMPARATOR

Trabecular Micro-Bypass Stent

Intervention Type DEVICE

Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.

Cataract Extraction

Intervention Type PROCEDURE

Cataract extraction via Phaco and PCIOL implant.

Interventions

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Goniotomy

Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.

Intervention Type PROCEDURE

Trabecular Micro-Bypass Stent

Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.

Intervention Type DEVICE

Cataract Extraction

Cataract extraction via Phaco and PCIOL implant.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No