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RiGOR: Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

Sponsor
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01645319
Collaborator
American Academy of Ophthalmology (Other), Jules Stein Eye Institute (Other)
2,597
Enrollment
1
Location
28.9
Duration (Months)
89.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    2597 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Open-Angle Glaucoma
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    White, non-hispanic - Medication Treatment Pathway
    White, non-Hispanic - Laser Surgery Treatment Pathway
    White, non-Hispanic - Incisional/Other Treatment Pathway
    Hispanic - Medication Treatment Pathway
    Hispanic - Laser Surgery Treatment Pathway
    Hispanic - Incisional/Other Surgery Treatment Pathway
    Asian - Medication Treatment Pathway
    Asian - Laser Surgery Treatment Pathway
    Asian - Incisional/Other Surgery Treatment Pathway
    Black - Medication Treatment Pathway
    Black - Laser Surgery Treatment Pathway
    Black - Incisional/Other Surgery Treatment Pathway

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcomes of interest are IOP, visual function, and quality of life. [12 Months]

    Secondary Outcome Measures

    1. Secondary outcomes of interest include visual field assessment, visual acuity, treatment complications and repeat surgeries. [12 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wills Eye Institute Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Agency for Healthcare Research and Quality (AHRQ)
    • American Academy of Ophthalmology
    • Jules Stein Eye Institute

    Investigators

    • Principal Investigator: Rich Gliklich, MD, Outcome DEcIDE Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Agency for Healthcare Research and Quality (AHRQ)
    ClinicalTrials.gov Identifier:
    NCT01645319
    Other Study ID Numbers:
    • HHSA29020050035I
    First Posted:
    Jul 20, 2012
    Last Update Posted:
    Jan 8, 2014
    Last Verified:
    Jul 1, 2012
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of Jan 8, 2014