NCT00221923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
16.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

19.3 years

First QC Date

September 14, 2005

Last Update Submit

July 2, 2021

Conditions

Keywords

Primary open angle glaucomaAfrican AmericanGlaucoma/pathologyGlaucoma/ physiopathologyNerve Fibers/pathologyRisk factor glaucoma

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama-Callahan Eye Foundation, Prof. Bldg.

Birmingham, Alabama, 35233, United States

Location

UCSD Hamilton Glaucoma Center

La Jolla, California, 92093-0946, United States

Location

New York Eye & Ear Infirmary

New York, New York, 10003, United States

Location

Related Publications (48)

  • 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.

    PMID: 10845599BACKGROUND
  • 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. doi: 10.1001/archopht.123.11.1547.

    PMID: 16286617BACKGROUND
  • 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.

    PMID: 9559499BACKGROUND
  • 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

    BACKGROUND
  • Wilson MR. Glaucoma in blacks: where do we go from here? JAMA. 1989 Jan 13;261(2):281-2. No abstract available.

    PMID: 2909027BACKGROUND
  • Munoz 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. doi: 10.1001/archopht.118.6.819.

    PMID: 10865321BACKGROUND
  • 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.

    PMID: 2056646BACKGROUND
  • 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. doi: 10.1056/NEJM199111143252005.

    PMID: 1922253BACKGROUND
  • Sample PA, Weinreb RN, Boynton RM. Acquired dyschromatopsia in glaucoma. Surv Ophthalmol. 1986 Jul-Aug;31(1):54-64. doi: 10.1016/0039-6257(86)90051-2.

    PMID: 3529468BACKGROUND
  • Sample PA, Weinreb RN. Color perimetry for assessment of primary open-angle glaucoma. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1869-75.

    PMID: 2211033BACKGROUND
  • 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.

    PMID: 19920588BACKGROUND
  • Sample PA, Johnson CA, Haegerstrom-Portnoy G, Adams AJ. Optimum parameters for short-wavelength automated perimetry. J Glaucoma. 1996 Dec;5(6):375-83.

    PMID: 8946293BACKGROUND
  • 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. doi: 10.1016/s0002-9394(14)71079-7.

    PMID: 9152072BACKGROUND
  • 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. doi: 10.1016/s0002-9394(99)80183-4.

    PMID: 9559728BACKGROUND
  • 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. doi: 10.1001/archopht.118.9.1231.

    PMID: 10980768BACKGROUND
  • Sample PA. What does functional testing tell us about optic nerve damage? Surv Ophthalmol. 2001 May;45 Suppl 3:S319-24; discussion S332-4. doi: 10.1016/s0039-6257(01)00196-5.

    PMID: 11377456BACKGROUND
  • 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.

    PMID: 11481263BACKGROUND
  • 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.

    PMID: 11773027BACKGROUND
  • 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. doi: 10.1016/s0002-9394(02)01577-5.

    PMID: 12140023BACKGROUND
  • 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. doi: 10.1016/s0002-9394(02)01886-x.

    PMID: 12566014BACKGROUND
  • Racette L, Wilson MR, Zangwill LM, Weinreb RN, Sample PA. Primary open-angle glaucoma in blacks: a review. Surv Ophthalmol. 2003 May-Jun;48(3):295-313. doi: 10.1016/s0039-6257(03)00028-6.

    PMID: 12745004BACKGROUND
  • 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. doi: 10.1001/archopht.121.4.458.

    PMID: 12695242BACKGROUND
  • 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. doi: 10.1016/j.ajo.2003.12.009.

    PMID: 15126151BACKGROUND
  • Sanchez-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. doi: 10.1016/j.ophtha.2004.04.017.

    PMID: 15465548BACKGROUND
  • 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. doi: 10.1167/iovs.03-0343.

    PMID: 15277482BACKGROUND
  • 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. doi: 10.1016/j.ajo.2004.07.003.

    PMID: 15629296BACKGROUND
  • Anderson DR. Standard perimetry. Ophthalmol Clin North Am. 2003 Jun;16(2):205-12, vi. doi: 10.1016/s0896-1549(03)00005-1.

    PMID: 12809158BACKGROUND
  • 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)

    BACKGROUND
  • 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).

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

    BACKGROUND
  • Mahmoudinezhad G, Moghimi S, Latif K, Brye N, Walker E, Nishida T, Du KH, Gunasegaran G, Wu JH, Liebmann JM, Fazio MA, Girkin CA, Zangwill LM, Weinreb RN. Number of macula optical coherence tomography scans needed to detect glaucoma progression. Br J Ophthalmol. 2025 May 30;109(6):675-681. doi: 10.1136/bjo-2023-324916.

  • Mahmoudinezhad G, Nishida T, Weinreb RN, Baxter SL, Chang AC, Nikkhoy N, Walker E, Liebmann JM, Girkin CA, Moghimi S. Associations of smoking and alcohol consumption with the development of open angle glaucoma: a retrospective cohort study. BMJ Open. 2023 Oct 4;13(10):e072163. doi: 10.1136/bmjopen-2023-072163.

  • Bowd C, Belghith A, Rezapour J, Christopher M, Jonas JB, Hyman L, Fazio MA, Weinreb RN, Zangwill LM. Multimodal Deep Learning Classifier for Primary Open Angle Glaucoma Diagnosis Using Wide-Field Optic Nerve Head Cube Scans in Eyes With and Without High Myopia. J Glaucoma. 2023 Oct 1;32(10):841-847. doi: 10.1097/IJG.0000000000002267. Epub 2023 Jul 19.

  • Orbach A, Ang GS, Camp AS, Welsbie DS, Medeiros FA, Girkin CA, Fazio MA, Oh WH, Weinreb RN, Zangwill LM, Wu Z. Qualitative Evaluation of the 10-2 and 24-2 Visual Field Tests for Detecting Central Visual Field Abnormalities in Glaucoma. Am J Ophthalmol. 2021 Sep;229:26-33. doi: 10.1016/j.ajo.2021.02.015. Epub 2021 Feb 21.

  • Melchior B, De Moraes CG, Paula JS, A Cioffi G, Girkin CA, Fazio MA, N Weinreb R, M Zangwill L, M Liebmann J. Relationship between mean follow-up intraocular pressure, rates of visual field progression and current target intraocular pressure guidelines. Br J Ophthalmol. 2022 Feb;106(2):229-233. doi: 10.1136/bjophthalmol-2020-317406. Epub 2020 Oct 31.

  • Wu Z, Medeiros FA, Weinreb RN, Girkin CA, Zangwill LM. Comparing 10-2 and 24-2 Visual Fields for Detecting Progressive Central Visual Loss in Glaucoma Eyes with Early Central Abnormalities. Ophthalmol Glaucoma. 2019 Mar-Apr;2(2):95-102. doi: 10.1016/j.ogla.2019.01.003. Epub 2019 Jan 14.

  • Wu Z, Medeiros FA, Weinreb RN, Girkin CA, Zangwill LM. Specificity of various cluster criteria used for the detection of glaucomatous visual field abnormalities. Br J Ophthalmol. 2020 Jun;104(6):822-826. doi: 10.1136/bjophthalmol-2019-314593. Epub 2019 Sep 17.

  • De Moraes CG, Hood DC, Thenappan A, Girkin CA, Medeiros FA, Weinreb RN, Zangwill LM, Liebmann JM. 24-2 Visual Fields Miss Central Defects Shown on 10-2 Tests in Glaucoma Suspects, Ocular Hypertensives, and Early Glaucoma. Ophthalmology. 2017 Oct;124(10):1449-1456. doi: 10.1016/j.ophtha.2017.04.021. Epub 2017 May 24.

  • Skaat A, De Moraes CG, Bowd C, Sample PA, Girkin CA, Medeiros FA, Ritch R, Weinreb RN, Zangwill LM, Liebmann JM; Diagnostic Innovations in Glaucoma Study and African Descent and Glaucoma Evaluation Study Groups. African Descent and Glaucoma Evaluation Study (ADAGES): Racial Differences in Optic Disc Hemorrhage and Beta-Zone Parapapillary Atrophy. Ophthalmology. 2016 Jul;123(7):1476-83. doi: 10.1016/j.ophtha.2016.03.025. Epub 2016 Apr 23.

  • Girkin CA, Nievergelt CM, Kuo JZ, Maihofer AX, Huisingh C, Liebmann JM, Ayyagari R, Weinreb RN, Ritch R, Zangwill LM; ADAGES Study Group. Biogeographic Ancestry in the African Descent and Glaucoma Evaluation Study (ADAGES): Association With Corneal and Optic Nerve Structure. Invest Ophthalmol Vis Sci. 2015 Mar 5;56(3):2043-9. doi: 10.1167/iovs.14-15719.

  • Rhodes LA, Huisingh C, Johnstone J, Fazio MA, Smith B, Wang L, Clark M, Downs JC, Owsley C, Girard MJ, Mari JM, Girkin CA. Peripapillary choroidal thickness variation with age and race in normal eyes. Invest Ophthalmol Vis Sci. 2015 Feb 24;56(3):1872-9. doi: 10.1167/iovs.14-16179.

  • Hu R, Marin-Franch I, Racette L. Prediction accuracy of a novel dynamic structure-function model for glaucoma progression. Invest Ophthalmol Vis Sci. 2014 Oct 30;55(12):8086-94. doi: 10.1167/iovs.14-14928.

  • Tatham AJ, Weinreb RN, Zangwill LM, Liebmann JM, Girkin CA, Medeiros FA. Estimated retinal ganglion cell counts in glaucomatous eyes with localized retinal nerve fiber layer defects. Am J Ophthalmol. 2013 Sep;156(3):578-587.e1. doi: 10.1016/j.ajo.2013.04.015. Epub 2013 Jun 7.

  • Tatham AJ, Weinreb RN, Zangwill LM, Liebmann JM, Girkin CA, Medeiros FA. The relationship between cup-to-disc ratio and estimated number of retinal ganglion cells. Invest Ophthalmol Vis Sci. 2013 May 7;54(5):3205-14. doi: 10.1167/iovs.12-11467.

  • Bowd C, Lee I, Goldbaum MH, Balasubramanian M, Medeiros FA, Zangwill LM, Girkin CA, Liebmann JM, Weinreb RN. Predicting glaucomatous progression in glaucoma suspect eyes using relevance vector machine classifiers for combined structural and functional measurements. Invest Ophthalmol Vis Sci. 2012 Apr 30;53(4):2382-9. doi: 10.1167/iovs.11-7951.

  • Racette L, Liebmann JM, Girkin CA, Zangwill LM, Jain S, Becerra LM, Medeiros FA, Bowd C, Weinreb RN, Boden C, Sample PA; ADAGES Group. African Descent and Glaucoma Evaluation Study (ADAGES): III. Ancestry differences in visual function in healthy eyes. Arch Ophthalmol. 2010 May;128(5):551-9. doi: 10.1001/archophthalmol.2010.58.

  • Girkin CA, Sample PA, Liebmann JM, Jain S, Bowd C, Becerra LM, Medeiros FA, Racette L, Dirkes KA, Weinreb RN, Zangwill LM; ADAGES Group. African Descent and Glaucoma Evaluation Study (ADAGES): II. Ancestry differences in optic disc, retinal nerve fiber layer, and macular structure in healthy subjects. Arch Ophthalmol. 2010 May;128(5):541-50. doi: 10.1001/archophthalmol.2010.49.

  • Sample PA, Girkin CA, Zangwill LM, Jain S, Racette L, Becerra LM, Weinreb RN, Medeiros FA, Wilson MR, De Leon-Ortega J, Tello C, Bowd C, Liebmann JM; African Descent and Glaucoma Evaluation Study Group. The African Descent and Glaucoma Evaluation Study (ADAGES): design and baseline data. Arch Ophthalmol. 2009 Sep;127(9):1136-45. doi: 10.1001/archophthalmol.2009.187.

Related Links

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Linda M Zangwill, Ph.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

September 1, 2002

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

July 6, 2021

Record last verified: 2021-07

Locations