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

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.

Study Overview

• Status: Completed
• Conditions: Open Angle Glaucoma

• Study Type: Observational
• Enrollment (Actual): 2597

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In the United States, the prevalence of open-angle glaucoma for all adults 40 years old and older is estimated to be 1.86%. Open-angle glaucoma affects an estimated 2.22 million people, and that will rise to 3.3 million in 2020 as the population ages in the United States. Worldwide, it is estimated that 66.8 million people have glaucoma. Glaucoma of all types is one of the leading causes of legal blindness in the country.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

12

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Agency for Healthcare Research and Quality (AHRQ)
• Collaborators: Jules Stein Eye Institute; American Academy of Ophthalmology
• Investigators: Principal Investigator: Rich Gliklich, MD, Outcome DEcIDE Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: January 7, 2014
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: HHSA29020050035I