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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01645319
Other study ID # HHSA29020050035I
Secondary ID
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


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
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