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

• Sponsor: New World Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02784249
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma	Procedure: Goniotomy; Device: Trabecular Micro-Bypass Stent; Procedure: Cataract Extraction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Goniotomy Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.	Procedure: Goniotomy; Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.; Procedure: Cataract Extraction; Cataract extraction via Phaco and PCIOL implant.
Active Comparator: Trabecular Micro-Bypass Stent Procedure: Device implantation 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.

Outcome Measures

Primary Outcome Measures

1. Percent reduction in mean IOP [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gundersen Health System	La Crosse	Wisconsin	United States	54601

Sponsors and Collaborators

• New World Medical, Inc.

Investigators

• Study Director: Luana Wilbur, BS, Pilot to Pivotal Consulting, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New World Medical, Inc.
• ClinicalTrials.gov Identifier: NCT02784249
• Other Study ID Numbers: C-16-04
• First Posted: May 27, 2016
• Last Update Posted: Jul 14, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by New World Medical, Inc.: Glaucoma; glaucoma surgery; ab interno
• Additional relevant MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle

Study Results

No Results Posted as of Jul 14, 2021