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African Descent and Glaucoma Evaluation Study (ADAGES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00221923
First received: September 14, 2005
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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
Primary Open Angle Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: African Descent and Glaucoma Evaluation Study (Formerly African Americans With Glaucoma Study)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Estimated Enrollment: 1540
Study Start Date: September 2002
Estimated Study Completion Date: February 2015
Groups/Cohorts
Healthy individuals
Persons at risk for or with primary open angle glaucoma

Detailed Description:

The purpose of the study is:

  1. 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..
  2. 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.
  3. 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.
  4. 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221923

Locations
United States, Alabama
University of Alabama-Callahan Eye Foundation, Prof. Bldg.
Birmingham, Alabama, United States, 35233
United States, California
UCSD Hamilton Glaucoma Center
La Jolla, California, United States, 92093-0946
United States, New York
New York Eye & Ear Infirmary
New York, New York, United States, 10003
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Linda M Zangwill, Ph.D. University of California, San Diego
Principal Investigator: Felipe Medeiros, MD, PhD University of California, San Diego
  More Information

Additional Information:
Publications:
Zangwill L, Knauer S, Williams JM, Weinreb RN, Retinal fiber layer assessment by scanning laser polarimetery, optical coherence tomography and retinal nerve fiber layer photography. In: Lemij HG, Schuman JS, eds. The Shape of Glaucoma, Quantitative Neural Imaging Techniques. The Hague Kugler Publications, 2000:239-252
Sample PA, Madrid ME, Weinreb RN. 1994. Evidence for a variety of functional defects in glaucoma suspect eyes. Journal of Glaucoma. 3652:S5-S18.
Racette L, Wilson MR, Zangwill LM, Weinreb RN, Sample PA. 2003. Glaucoma in the black American population. A review. Surv Ophthalmol 48:295-313
Stamper R. L., Sample P. A. and Girkin C. A. (Eds.). (2003). Assessing Visual Function in Clinical Practice. Ophthalmology Clinics of North America, Vol.16, Number . In Anderson D.R.(ed.) Standard Perimetry (pp. 205-212).
Stamper R. L., Sample P. A. and Girkin C. A. (Eds.). (2003). Assessing Visual Function in Clinical Practice. Ophthalmology Clinics of North America, Vol.16, Number . In Anderson J.A and Johnson C.A. (eds.). Frequency-Doubling Technology Perminetry (pp213-226)
Stamper R. L., Sample P. A. and Girkin C. A. (Eds.). (2003). Assessing Visual Function in Clinical Practice. Ophthalmology Clinics of North America, Vol.16, Number 2. In Racette L and Sample P.A. (eds.). Short wave automated perimetry. (pp227 -236).
Weinreb R.N. and Greve E.L. (Eds.). (2004). Glaucoma diagnosis. Structure and function. The Hague, The Netherlands: Kugler Publications.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Donald Everett/Program Officer, National Eye Institute
ClinicalTrials.gov Identifier: NCT00221923     History of Changes
Other Study ID Numbers: NEI U10 EY 14267
Study First Received: September 14, 2005
Last Updated: August 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Primary open angle glaucoma
African American
Glaucoma/pathology
Glaucoma/ physiopathology
Nerve Fibers/pathology
Risk factor glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 27, 2014