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Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty

Primary Purpose

Primary Open-Angle Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stents
Laser
Laser Trabeculoplasty
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-Angle Glaucoma

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Open angle Glaucoma

Exclusion Criteria:

  • Active corneal inflammation or edema
  • Choroidal detachment, effusion, choroiditis

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgical

Laser

Arm Description

Implantation of two Trabecular Meshwork stents into the study eye

Laser Trabeculoplasty

Outcomes

Primary Outcome Measures

IOP reduction

Secondary Outcome Measures

% IOP reduction

Full Information

First Posted
November 6, 2014
Last Updated
December 20, 2022
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02327312
Brief Title
Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Study Start Date
December 16, 2014 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
August 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical
Arm Type
Experimental
Arm Description
Implantation of two Trabecular Meshwork stents into the study eye
Arm Title
Laser
Arm Type
Active Comparator
Arm Description
Laser Trabeculoplasty
Intervention Type
Device
Intervention Name(s)
Stents
Intervention Description
Two Trabecular meshwork Micro-Bypass stents into the study eye
Intervention Type
Procedure
Intervention Name(s)
Laser
Intervention Description
Laser Trabeculoplasty
Intervention Type
Device
Intervention Name(s)
Laser Trabeculoplasty
Primary Outcome Measure Information:
Title
IOP reduction
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
% IOP reduction
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Open angle Glaucoma Exclusion Criteria: Active corneal inflammation or edema Choroidal detachment, effusion, choroiditis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Stephens, OD
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Chair
Facility Information:
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35943114
Citation
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.
Results Reference
derived

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Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty

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