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Clinical Trials/NCT01645319
NCT01645319
Completed
Not Applicable

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

Agency for Healthcare Research and Quality (AHRQ)1 site in 1 country2,597 target enrollmentFebruary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Open Angle Glaucoma
Sponsor
Agency for Healthcare Research and Quality (AHRQ)
Enrollment
2597
Locations
1
Primary Endpoint
The primary outcomes of interest are IOP, visual function, and quality of life.
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
July 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Agency for Healthcare Research and Quality (AHRQ)
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The primary outcomes of interest are IOP, visual function, and quality of life.

Time Frame: 12 Months

Secondary Outcomes

  • Secondary outcomes of interest include visual field assessment, visual acuity, treatment complications and repeat surgeries.(12 Months)

Study Sites (1)

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