Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma
NCT ID: NCT01645319
Last Updated: 2014-01-08
Study Results
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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COMPLETED
2597 participants
OBSERVATIONAL
2011-02-28
2013-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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
* Includes patients with normal-tension glaucoma, pigmentary glaucoma and pseudoexfoliation.
* Patients willing to complete visual function and quality of life questionnaires
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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American Academy of Ophthalmology
OTHER
Jules Stein Eye Institute
OTHER
Agency for Healthcare Research and Quality (AHRQ)
FED
Responsible Party
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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
Countries
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Other Identifiers
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HHSA29020050035I
Identifier Type: -
Identifier Source: org_study_id
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