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

Not Applicable

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Procedure: Goniotomy; Device: Trabecular Micro-Bypass Stent; Procedure: Cataract Extraction

• Registration Number: NCT02784249
• Lead Sponsor: New World Medical, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Study Start: 2016-06
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

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Exclusion Criteria

• Any glaucoma diagnosis other than those noted in inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goniotomy	Goniotomy	Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.
Goniotomy	Cataract Extraction	Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.
Trabecular Micro-Bypass Stent	Cataract Extraction	Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
Trabecular Micro-Bypass Stent	Trabecular Micro-Bypass Stent	Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant.

Primary Outcome Measures

Name	Time	Method
Percent reduction in mean IOP	12 months

Trial Locations

Locations (1)

Gundersen Health System; 🇺🇸 La Crosse, Wisconsin, United States