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

NCT ID: NCT02327312

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-16

Study Completion Date

2020-08-11

Brief Summary

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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

Detailed Description

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Conditions

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Primary Open-Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical

Implantation of two Trabecular Meshwork stents into the study eye

Group Type EXPERIMENTAL

Stents

Intervention Type DEVICE

Two Trabecular meshwork Micro-Bypass stents into the study eye

Laser

Laser Trabeculoplasty

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type PROCEDURE

Laser Trabeculoplasty

Laser Trabeculoplasty

Intervention Type DEVICE

Interventions

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Stents

Two Trabecular meshwork Micro-Bypass stents into the study eye

Intervention Type DEVICE

Laser

Laser Trabeculoplasty

Intervention Type PROCEDURE

Laser Trabeculoplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Open angle Glaucoma

Exclusion Criteria

* Active corneal inflammation or edema
* Choroidal detachment, effusion, choroiditis
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kerry Stephens, OD

Role: STUDY_CHAIR

Glaukos Corporation

Locations

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Glendale, Arizona, United States

Site Status

Fayetteville, Arkansas, United States

Site Status

Hemet, California, United States

Site Status

Cape Coral, Florida, United States

Site Status

Elizabeth City, North Carolina, United States

Site Status

Memphis, Tennessee, United States

Site Status

Fort Worth, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Racine, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35943114 (View on PubMed)

Other Identifiers

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GC-004

Identifier Type: -

Identifier Source: org_study_id