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

Completed · Not applicable

Conditions studied: Open Angle Glaucoma

In brief

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.

Key facts

Study ID

NCT02784249

Run by

New World Medical, Inc.

People needed

166

Starts

2016-06-01

Expected to finish

2018-12-01

Last updated by the study team

2021-07-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any glaucoma diagnosis other than those noted in inclusion criteria

Where it is running

• Gundersen Health System — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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