Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
1540 participants
Study Classification
OBSERVATIONAL
Study Start Date
2002-09-30
Study Completion Date
2022-07-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Primary Open Angle Glaucoma
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Eye Institute (NEI)
NIH
Sponsor Role
collaborator
University of California, San Diego
OTHER
Sponsor Role
lead
Responsible Party
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Linda Zangwill
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Linda M Zangwill, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of Alabama-Callahan Eye Foundation, Prof. Bldg.
Birmingham, Alabama, United States
Site Status
UCSD Hamilton Glaucoma Center
La Jolla, California, United States
Site Status
New York Eye & Ear Infirmary
New York, New York, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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
Reference Type
BACKGROUND
Wilson MR. Glaucoma in blacks: where do we go from here? JAMA. 1989 Jan 13;261(2):281-2. No abstract available.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Sample PA, Weinreb RN. Color perimetry for assessment of primary open-angle glaucoma. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1869-75.
Reference Type
BACKGROUND
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.
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BACKGROUND
Sample PA, Johnson CA, Haegerstrom-Portnoy G, Adams AJ. Optimum parameters for short-wavelength automated perimetry. J Glaucoma. 1996 Dec;5(6):375-83.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
Anderson DR. Standard perimetry. Ophthalmol Clin North Am. 2003 Jun;16(2):205-12, vi. doi: 10.1016/s0896-1549(03)00005-1.
Reference Type
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 . In Anderson J.A and Johnson C.A. (eds.). Frequency-Doubling Technology Perminetry (pp213-226)
Reference Type
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).
Reference Type
BACKGROUND
Weinreb R.N. and Greve E.L. (Eds.). (2004). Glaucoma diagnosis. Structure and function. The Hague, The Netherlands: Kugler Publications.
Reference Type
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Related Links
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https://shileyeye.ucsd.edu
Website at UCSD
Other Identifiers
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