Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty
1 other identifier
interventional
91
1 country
9
Brief Summary
To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
Longer than P75 for not_applicable
9 active sites
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
November 6, 2014
CompletedStudy Start
First participant enrolled
December 16, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2020
CompletedDecember 22, 2022
December 1, 2022
4.5 years
November 6, 2014
December 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
IOP reduction
up to 24 months
Secondary Outcomes (1)
% IOP reduction
up to 24 months
Study Arms (2)
Surgical
EXPERIMENTALImplantation of two Trabecular Meshwork stents into the study eye
Laser
ACTIVE COMPARATORLaser Trabeculoplasty
Interventions
Eligibility Criteria
You may qualify if:
- Open angle Glaucoma
You may not qualify if:
- Active corneal inflammation or edema
- Choroidal detachment, effusion, choroiditis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Glendale, Arizona, 85306, United States
Unknown Facility
Fayetteville, Arkansas, 72704, United States
Unknown Facility
Hemet, California, 92545, United States
Unknown Facility
Cape Coral, Florida, 33904, United States
Unknown Facility
Elizabeth City, North Carolina, 27909, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Fort Worth, Texas, 76102, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Racine, Wisconsin, 53405, United States
Related Publications (1)
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
PMID: 35943114DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kerry Stephens, OD
Glaukos Corporation
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
November 6, 2014
First Posted
December 30, 2014
Study Start
December 16, 2014
Primary Completion
May 31, 2019
Study Completion
August 11, 2020
Last Updated
December 22, 2022
Record last verified: 2022-12