Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

Study Overview
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Brief Summary
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The primary objectives of the study are: 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. 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.

Official Title
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A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Open-Angle Glaucoma

Conditions
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Open Angle Glaucoma

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| White, non-hispanic - Medication Treatment Pathway<br> | |
| White, non-Hispanic - Laser Surgery Treatment Pathway<br> | |
| White, non-Hispanic - Incisional/Other Treatment Pathway<br> | |
| Hispanic - Medication Treatment Pathway<br> | |
| Hispanic - Laser Surgery Treatment Pathway<br> | |
| Hispanic - Incisional/Other Surgery Treatment Pathway<br> | |
| Asian - Medication Treatment Pathway<br> | |
| Asian - Laser Surgery Treatment Pathway<br> | |
| Asian - Incisional/Other Surgery Treatment Pathway<br> | |
| Black - Medication Treatment Pathway<br> | |
| Black - Laser Surgery Treatment Pathway<br> | |
| Black - Incisional/Other Surgery Treatment Pathway<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcomes of interest are IOP, visual function, and quality of life. |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes of interest include visual field assessment, visual acuity, treatment complications and repeat surgeries. |  | 12 Months |