- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02327312
Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty
December 20, 2022 updated by: Glaukos Corporation
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Glendale, Arizona, United States, 85306
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72704
-
-
California
-
Hemet, California, United States, 92545
-
-
Florida
-
Cape Coral, Florida, United States, 33904
-
-
North Carolina
-
Elizabeth City, North Carolina, United States, 27909
-
-
Tennessee
-
Memphis, Tennessee, United States, 38120
-
-
Texas
-
Fort Worth, Texas, United States, 76102
-
San Antonio, Texas, United States, 78229
-
-
Wisconsin
-
Racine, Wisconsin, United States, 53405
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Open angle Glaucoma
Exclusion Criteria:
- Active corneal inflammation or edema
- Choroidal detachment, effusion, choroiditis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgical
Implantation of two Trabecular Meshwork stents into the study eye
|
Two Trabecular meshwork Micro-Bypass stents into the study eye
|
Active Comparator: Laser
Laser Trabeculoplasty
|
Laser Trabeculoplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
IOP reduction
Time Frame: up to 24 months
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
% IOP reduction
Time Frame: up to 24 months
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2014
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
August 11, 2020
Study Registration Dates
First Submitted
November 6, 2014
First Submitted That Met QC Criteria
December 29, 2014
First Posted (Estimate)
December 30, 2014
Study Record Updates
Last Update Posted (Estimate)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 20, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GC-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Open-Angle Glaucoma
-
Omar SaidCompletedGlaucoma,Primary Open-Angle ,Primary Angle ClosureEgypt
-
Glaucot Teknoloji Anonim SirketiRecruitingPrimary Open-Angle GlaucomaTurkey
-
China Medical University HospitalCompletedEffect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle GlaucomaPrimary Open-angle GlaucomaTaiwan
-
InnFocus Inc.CompletedPrimary Open-angle GlaucomaSpain, United States, United Kingdom, France, Italy
-
Rehab mahmoud abdelhamid mohamedCairo UniversityCompletedPrimary Open-angle GlaucomaEgypt
-
Cairo UniversityUniversity of LuebeckUnknown
-
Xiaodong ZhouCompletedPrimary Open-angle Glaucoma
-
Qlaris Bio, Inc.RecruitingPrimary Open Angle Glaucoma of Both Eyes | Primary Open Angle Glaucoma (POAG) | Primary Open-Angle Glaucoma, Unspecified Eye | Ocular Hypertension (OHT)United States
-
Peking UniversityRecruitingPrimary Open Angle Glaucoma | Ocular Hypertension | Primary Open Angle Glaucoma of Both Eyes | Primary Open-Angle Glaucoma, Unspecified Eye | Suspect GlaucomaChina
-
University of Alabama at BirminghamNational Institute on Aging (NIA)Active, not recruiting
Clinical Trials on Stents
-
Fujian Medical UniversityJetmed(Beijing)Co.,Ltd.CompletedCoronary Heart DiseaseChina
-
Changhai HospitalUnknownAortic Aneurysm, Abdominal | Aortic Aneurysm | Aortic Aneurysm, Thoracic | Aortic Aneurysm, ThoracoabdominalChina
-
Washington University School of MedicineMassachusetts General Hospital; Ontario Clinical Oncology Group (OCOG); St. Luke...RecruitingDeep Vein Thrombosis | Post Thrombotic Syndrome | Venous Insufficiency | Venous Leg Ulcer | Venous Stasis | Venous RefluxUnited States
-
Peking University Third HospitalRecruitingBile Duct StrictureChina
-
Peking University Third HospitalNot yet recruiting
-
Cook Group IncorporatedCompleted
-
Peking University Third HospitalRecruitingPancreatic PseudocystChina
-
Hospital de Clinicas de Porto AlegreUnknownTracheobronchomalaciaBrazil
-
Yonsei UniversityWithdrawnPatients in the Treatment of Subjects With All-comer Who Are to Undergo PCI
-
Inje UniversityCompletedPeriampullary Cancer | Disorder of Bile Duct Stent | Complications of Surgical Procedures or Medical CareKorea, Republic of