African Descent and Glaucoma Evaluation Study (ADAGES)

July 2, 2021 updated by: Linda Zangwill, University of California, San Diego

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

1540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama-Callahan Eye Foundation, Prof. Bldg.
- California
  - La Jolla, California, United States, 92093-0946
    - UCSD Hamilton Glaucoma Center
- New York
  - New York, New York, United States, 10003
    - New York Eye & Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults of African or European descent based on self-report.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Eye Institute (NEI)

Investigators

Principal Investigator: Linda M Zangwill, Ph.D., University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Website at UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria