Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

NCT ID: NCT01645319

Last Updated: 2014-01-08

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

COMPLETED

Total Enrollment

2597 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-07-31

Brief Summary

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The primary objectives of the study are:

1. To compare the proportion of patients who achieve a successful response to treatment (reduction in Intraocular Pressure (IOP) of \>15%) between patients treated with laser surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with patients receiving additional medications, at 1-year post-treatment initiation.
2. To compare the proportion of patients who achieve a successful response to treatment (reduction in IOP of \>15%) between patients treated with other procedures (including incisional surgery, drainage device procedures, and other glaucoma procedures) with patients receiving additional medications, at 1-year-post-treatment initiation.

The study is a prospective, observational cohort study and will not provide or recommend any treatment. Patients who have failed initial medical therapy with two glaucoma medications will be identified and enrolled at the time of scheduling of a laser surgery procedure or other procedure such as incisional surgery or drainage device, or initiation of an additional course of therapy with medication as determined by their physician. This inception cohort of new initiators of laser surgical treatment, other procedures, or additional medical therapy will be followed for 12 months. All decisions regarding treatment are solely at the discretion of the physician in accordance with their usual practice. Enrollment is expected to begin in February 2011 and continue through 12 months of follow-up after enrollment targets have been reached.

Detailed Description

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Conditions

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Open Angle Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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White, non-hispanic - Medication Treatment Pathway

No interventions assigned to this group

White, non-Hispanic - Laser Surgery Treatment Pathway

No interventions assigned to this group

White, non-Hispanic - Incisional/Other Treatment Pathway

No interventions assigned to this group

Hispanic - Medication Treatment Pathway

No interventions assigned to this group

Hispanic - Laser Surgery Treatment Pathway

No interventions assigned to this group

Hispanic - Incisional/Other Surgery Treatment Pathway

No interventions assigned to this group

Asian - Medication Treatment Pathway

No interventions assigned to this group

Asian - Laser Surgery Treatment Pathway

No interventions assigned to this group

Asian - Incisional/Other Surgery Treatment Pathway

No interventions assigned to this group

Black - Medication Treatment Pathway

No interventions assigned to this group

Black - Laser Surgery Treatment Pathway

No interventions assigned to this group

Black - Incisional/Other Surgery Treatment Pathway

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All adult patients with open-angle glaucoma who have a new or change in therapy (decision to proceed to laser or incisional surgery or initiate a new or additional course of medication).
* Includes patients with normal-tension glaucoma, pigmentary glaucoma and pseudoexfoliation.
* Patients willing to complete visual function and quality of life questionnaires

Exclusion Criteria

* Patients currently treated with four or more glaucoma medications (at time of enrollment).
* Patients with no light perception, or otherwise not eligible for further treatment
* Patients who have neovascular glaucoma, patients with uveitis-associated glaucoma, or patients with angle recession glaucoma.
* Patients with primary angle-closure or secondary angle-closure glaucoma
* Patients who have had prior incisional surgery for glaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Ophthalmology

OTHER

Sponsor Role collaborator

Jules Stein Eye Institute

OTHER

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rich Gliklich, MD

Role: PRINCIPAL_INVESTIGATOR

Outcome DEcIDE Center

Locations

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Wills Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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HHSA29020050035I

Identifier Type: -

Identifier Source: org_study_id

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