Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

NCT01645319 | Completed

• 1 other identifier: HHSA29020050035I
• Study Type: observational
• Target: 2,597
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of the study are:

1. 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. 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.

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

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

  12 Months

Secondary Outcomes (1)

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

  12 Months

Study Arms (12)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Rich Gliklich, MD

  Outcome DEcIDE Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: July 20, 2012
• Study Start: February 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 8, 2014

Record last verified: 2012-07

Locations

US (1)