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NCT02784249 Clinical Trial

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

Open Angle Glaucoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02784249
Other study ID # C-16-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2018

Study information
Verified date July 2021
Source New World Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Gundersen Health System La Crosse Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
New World Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent reduction in mean IOP 12 months
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