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OpenTrials
Completed

NCT Number: NCT02784249

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

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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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goniotomy

Procedure

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

Trabecular Micro-Bypass Stent

Device

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

Cataract Extraction

Procedure

Cataract extraction via Phaco and PCIOL implant.

Primary outcomes

  1. Percent reduction in mean IOP

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

New World Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 27, 2016
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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