Back to resultsA Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction
Primary Purpose
Open Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goniotomy
Trabecular Micro-Bypass Stent
Cataract Extraction
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Glaucoma, glaucoma surgery, ab interno
Eligibility Criteria
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
Sites / Locations
- Gundersen Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Goniotomy
Trabecular Micro-Bypass Stent
Arm Description
Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.
Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
Outcomes
Primary Outcome Measures
Percent reduction in mean IOP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784249
Brief Title
A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction
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 Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New World Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
Glaucoma, glaucoma surgery, ab interno
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Goniotomy
Arm Type
Experimental
Arm Description
Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.
Arm Title
Trabecular Micro-Bypass Stent
Arm Type
Active Comparator
Arm Description
Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
Intervention Type
Procedure
Intervention Name(s)
Goniotomy
Intervention Description
Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.
Intervention Type
Device
Intervention Name(s)
Trabecular Micro-Bypass Stent
Intervention Description
Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
Intervention Type
Procedure
Intervention Name(s)
Cataract Extraction
Intervention Description
Cataract extraction via Phaco and PCIOL implant.
Primary Outcome Measure Information:
Title
Percent reduction in mean IOP
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luana Wilbur, BS
Organizational Affiliation
Pilot to Pivotal Consulting, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction
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