Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

Completed

• Conditions: Open Angle Glaucoma

• Registration Number: NCT01645319
• Lead Sponsor: Agency for Healthcare Research and Quality (AHRQ)

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-10-20
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2597

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes of interest are IOP, visual function, and quality of life.	12 Months

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes of interest include visual field assessment, visual acuity, treatment complications and repeat surgeries.	12 Months

Trial Locations

Locations (1)

Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States