Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01645319

Acronym

RiGOR

Enrollment

2597

Registered

2012-07-20

Start date

2011-02-28

Completion date

2013-07-31

Last updated

2014-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results