NCT02784249

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: New World Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
PROCEDURE	Goniotomy	Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.
DEVICE	Trabecular Micro-Bypass Stent	Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
PROCEDURE	Cataract Extraction	Cataract extraction via Phaco and PCIOL implant.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2016-05-27
• Last updated: 2021-07-14

Locations

1 site across 1 country: United States