Open Angle Glaucoma Clinical Trial
— RiGOROfficial title:
A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Open-Angle Glaucoma
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.
Status | Completed |
Enrollment | 2597 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Wills Eye Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Agency for Healthcare Research and Quality (AHRQ) | American Academy of Ophthalmology, Jules Stein Eye Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcomes of interest are IOP, visual function, and quality of life. | 12 Months | No | |
Secondary | Secondary outcomes of interest include visual field assessment, visual acuity, treatment complications and repeat surgeries. | 12 Months | No |
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