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

New World Medical

Status: Completed

Conditions: Open Angle Glaucoma

Treatments: Device: Trabecular Micro-Bypass Stent; Procedure: Goniotomy; Procedure: Cataract Extraction

Study type: Interventional

Funder types: Industry

Identifiers

NCT02784249

C-16-04

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Goniotomy

Experimental group

Description:

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

Treatment:

Procedure: Cataract Extraction

Procedure: Goniotomy

Trabecular Micro-Bypass Stent

Active Comparator group

Description:

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

Treatment:

Procedure: Cataract Extraction

Device: Trabecular Micro-Bypass Stent