Skip to main content
OpenTrials
Completed

NCT Number: NCT01645319

Comparative Effectiveness of Treatment Strategies for Primary 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 12 Months

Secondary outcomes

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

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ)

Fed

Collaborators

  • American Academy of Ophthalmology
  • Jules Stein Eye Institute

Registry information

Official study title

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

Acronym: RiGOR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.