ADAGES: African Descent and Glaucoma Evaluation Study

Sponsor

University of California, San Diego (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT00221923

Collaborator

National Eye Institute (NEI) (NIH)

1,540

Enrollment

Locations

238

Anticipated Duration (Months)

513.3

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

According to the National Eye Institute, Glaucoma affects about three million Americans. Among Blacks in the United States, open- angle glaucoma is the leading cause of irreversible visual loss. Glaucoma is four times more likely to develop in Blacks than in Whites.

This is a prospective longitudinal, multi- site observational cohort study designed to obtain visual function and optic nerve structure data on eyes of Black and White Americans. The investigators will evaluate the relationship between changes in the structure of the eye and the vision loss caused by glaucoma.This is the first study where both populations are matched for quality of care and equal access to care.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma

Detailed Description

The purpose of the study is:

To further determine the nature of vision loss and optic nerve structural change associated with glaucoma. Using recently developed measures of visual function and techniques for imaging the eye, we will use a multivariate approach for analysis of the functional and structural changes associated with glaucoma to delineate further the relationship of these changes to the underlying physiological mechanisms..
To evaluate and improve new diagnostic and monitoring techniques encompassing measures of visual function and optic nerve and retina nerve fiber layer structure and to compare the rate and patterns of progression of glaucomatous damage in Black and White eyes.
To improve techniques for evaluation of current management and new therapies for glaucoma as they become available. We will expand our analysis using multivariate techniques incorporating visual function, optic nerve structure, and various risk factors to improve detection of true change. We will determine whether the benefits found in Whites using visual function specific perimetry and optic disc imaging for earlier detection and for monitoring progression are also found for Blacks.
To determine the quantitative temporal relationships between recognizable optic nerve damage and measurable visual field loss and how these relationships differ among Black and White patients. Using new techniques with improved sensitivity, the detection and monitoring of early optic disc defects may provide profiles of people at risk for developing glaucomatous visual function loss thus better defining target populations for treatment.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1540 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

African Descent and Glaucoma Evaluation Study (Formerly African Americans With Glaucoma Study)

Actual Study Start Date :

Sep 1, 2002

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Healthy individuals They will be considered if they are above 30 years old. There is no upper age limit. Subject can be either male or female, and from African or European Descent. They must speak, read, and understand English. They can be diagnosed with other health disorders.
Persons at risk for or with primary open angle glaucoma They will be considered if they are above 30 years old. There is no upper age limit. Subject can be either male or female, and from African or European Descent. They must speak, read, and understand English. They can be diagnosed with other health disorders.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Open angles
Best-corrected acuity of 20/40 or better
Spherical refraction within + 5.0 D, and cylinder within + 3.0 D with plus OR minus cylinders
≥ 18 years old
A family history of glaucoma is allowed
Ability to obtain adequate or better quality stereophotographs
Ability to do reliable standard Humphrey 30-2 or 24-2 visual fields
Participants with glaucoma or at risk for glaucoma or healthy controls

Exclusion Criteria:

History of intraocular surgery (except uncomplicated cataract or glaucoma surgery)
Problems other than Glaucoma affecting color vision
Non glaucomatous secondary causes of elevated IOP ( e.g. iridocyclitis, trauma)
Other intraocular eye disease
Other diseases affecting visual field (e:g pituitary lesions, demyelinating diseases, HIV+ or AIDS, or diabetic retinopathy) with medications known to affect visual field sensitivity
Problems other than Glaucoma affecting color vision

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama-Callahan Eye Foundation, Prof. Bldg.	Birmingham	Alabama	United States	35233
2	UCSD Hamilton Glaucoma Center	La Jolla	California	United States	92093-0946
3	New York Eye & Ear Infirmary	New York	New York	United States	10003