African Descent and Glaucoma Evaluation Study

Primary Open Angle Glaucoma Clinical Trial

— ADAGES  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00221923
• Other study ID #: NEI U10 EY 14267
• Secondary ID: R01EY023704R01EY
• Status: Enrolling by invitation
• Start date: September 2002
• Est. completion date: July 2022

Study information

• Verified date: July 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1540
• Est. completion date: July 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Locations

Country	Name	City	State
United States	University of Alabama-Callahan Eye Foundation, Prof. Bldg.	Birmingham	Alabama
United States	UCSD Hamilton Glaucoma Center	La Jolla	California
United States	New York Eye & Ear Infirmary	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (30)

Anton A, Yamagishi N, Zangwill L, Sample PA, Weinreb RN. Mapping structural to functional damage in glaucoma with standard automated perimetry and confocal scanning laser ophthalmoscopy. Am J Ophthalmol. 1998 Apr;125(4):436-46. — View Citation

Bathija R, Zangwill L, Berry CC, Sample PA, Weinreb RN. Detection of early glaucomatous structural damage with confocal scanning laser tomography. J Glaucoma. 1998 Apr;7(2):121-7. — View Citation

Boden C, Blumenthal EZ, Pascual J, McEwan G, Weinreb RN, Medeiros F, Sample PA. Patterns of glaucomatous visual field progression identified by three progression criteria. Am J Ophthalmol. 2004 Dec;138(6):1029-36. — View Citation

Bowd C, Zangwill LM, Berry CC, Blumenthal EZ, Vasile C, Sanchez-Galeana C, Bosworth CF, Sample PA, Weinreb RN. Detecting early glaucoma by assessment of retinal nerve fiber layer thickness and visual function. Invest Ophthalmol Vis Sci. 2001 Aug;42(9):1993-2003. — View Citation

Girkin CA, Emdadi A, Sample PA, Blumenthal EZ, Lee AC, Zangwill LM, Weinreb RN. Short-wavelength automated perimetry and standard perimetry in the detection of progressive optic disc cupping. Arch Ophthalmol. 2000 Sep;118(9):1231-6. — View Citation

Goldbaum MH, Sample PA, Chan K, Williams J, Lee TW, Blumenthal E, Girkin CA, Zangwill LM, Bowd C, Sejnowski T, Weinreb RN. Comparing machine learning classifiers for diagnosing glaucoma from standard automated perimetry. Invest Ophthalmol Vis Sci. 2002 Jan;43(1):162-9. — View Citation

Javitt JC, McBean AM, Nicholson GA, Babish JD, Warren JL, Krakauer H. Undertreatment of glaucoma among black Americans. N Engl J Med. 1991 Nov 14;325(20):1418-22. — View Citation

Johnson CA, Sample PA, Cioffi GA, Liebmann JR, Weinreb RN. Structure and function evaluation (SAFE): I. criteria for glaucomatous visual field loss using standard automated perimetry (SAP) and short wavelength automated perimetry (SWAP). Am J Ophthalmol. 2002 Aug;134(2):177-85. — View Citation

Medeiros FA, Sample PA, Weinreb RN. Corneal thickness measurements and visual function abnormalities in ocular hypertensive patients. Am J Ophthalmol. 2003 Feb;135(2):131-7. — View Citation

Medeiros FA, Sample PA, Weinreb RN. Frequency doubling technology perimetry abnormalities as predictors of glaucomatous visual field loss. Am J Ophthalmol. 2004 May;137(5):863-71. — View Citation

Muñoz B, West SK, Rubin GS, Schein OD, Quigley HA, Bressler SB, Bandeen-Roche K. Causes of blindness and visual impairment in a population of older Americans: The Salisbury Eye Evaluation Study. Arch Ophthalmol. 2000 Jun;118(6):819-25. — View Citation

Racette L, Boden C, Kleinhandler SL, Girkin CA, Liebmann JM, Zangwill LM, Medeiros FA, Bowd C, Weinreb RN, Wilson MR, Sample PA. Differences in visual function and optic nerve structure between healthy eyes of blacks and whites. Arch Ophthalmol. 2005 Nov;123(11):1547-53. — View Citation

Racette L, Wilson MR, Zangwill LM, Weinreb RN, Sample PA. 2003. Glaucoma in the black American population. A review. Surv Ophthalmol 48:295-313

Sample PA, Bosworth CF, Blumenthal EZ, Girkin C, Weinreb RN. Visual function-specific perimetry for indirect comparison of different ganglion cell populations in glaucoma. Invest Ophthalmol Vis Sci. 2000 Jun;41(7):1783-90. — View Citation

Sample PA, Chan K, Boden C, Lee TW, Blumenthal EZ, Weinreb RN, Bernd A, Pascual J, Hao J, Sejnowski T, Goldbaum MH. Using unsupervised learning with variational bayesian mixture of factor analysis to identify patterns of glaucomatous visual field defects. Invest Ophthalmol Vis Sci. 2004 Aug;45(8):2596-605. — View Citation

Sample PA, Johnson CA, Haegerstrom-Portnoy G, Adams AJ. Optimum parameters for short-wavelength automated perimetry. J Glaucoma. 1996 Dec;5(6):375-83. — View Citation

Sample PA, Madrid ME, Weinreb RN. Evidence for a variety of functional defects in glaucoma-suspect eyes. J Glaucoma. 1994 Summer;3 Suppl 1:S5-18. — View Citation

Sample PA, Weinreb RN, Boynton RM. Acquired dyschromatopsia in glaucoma. Surv Ophthalmol. 1986 Jul-Aug;31(1):54-64. Review. — View Citation

Sample PA, Weinreb RN. Color perimetry for assessment of primary open-angle glaucoma. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1869-75. — View Citation

Sample PA. What does functional testing tell us about optic nerve damage? Surv Ophthalmol. 2001 May;45 Suppl 3:S319-24; discussion S332-4. Review. — View Citation

Sánchez-Galeana CA, Bowd C, Zangwill LM, Sample PA, Weinreb RN. Short-wavelength automated perimetry results are correlated with optical coherence tomography retinal nerve fiber layer thickness measurements in glaucomatous eyes. Ophthalmology. 2004 Oct;111(10):1866-72. — View Citation

Schiefer U, Flad M, Stumpp F, Malsam A, Paetzold J, Vonthein R, Denk PO, Sample PA. Increased detection rate of glaucomatous visual field damage with locally condensed grids: a comparison between fundus-oriented perimetry and conventional visual field examination. Arch Ophthalmol. 2003 Apr;121(4):458-65. — View Citation

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).

Tielsch JM, Sommer A, Katz J, Royall RM, Quigley HA, Javitt J. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA. 1991 Jul 17;266(3):369-74. — View Citation

Weinreb R.N. and Greve E.L. (Eds.). (2004). Glaucoma diagnosis. Structure and function. The Hague, The Netherlands: Kugler Publications.

Wilson MR. Glaucoma in blacks: where do we go from here? JAMA. 1989 Jan 13;261(2):281-2. — View Citation

Yamagishi N, Anton A, Sample PA, Zangwill L, Lopez A, Weinreb RN. Mapping structural damage of the optic disk to visual field defect in glaucoma. Am J Ophthalmol. 1997 May;123(5):667-76. — View Citation

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

* Note: There are 30 references in all — Click here to view all references

External Links

•   Website at UCSD