Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

Open Angle Glaucoma Clinical Trial

— RiGOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645319
• Other study ID #: HHSA29020050035I
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: January 7, 2014
• Start date: February 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2012
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Locations

Country	Name	City	State
United States	Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Agency for Healthcare Research and Quality (AHRQ)	American Academy of Ophthalmology, Jules Stein Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

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