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
1 other identifier
interventional
166
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 14, 2021
July 1, 2021
1.5 years
May 24, 2016
July 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent reduction in mean IOP
12 months
Study Arms (2)
Goniotomy
EXPERIMENTALProcedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.
Trabecular Micro-Bypass Stent
ACTIVE COMPARATORProcedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
Interventions
Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.
Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
Cataract extraction via Phaco and PCIOL implant.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luana Wilbur, BS
Pilot to Pivotal Consulting, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2016
First Posted
May 27, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
July 14, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share