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Diagnostic Innovations in Glaucoma Study
This study is currently recruiting participants.
Verified by University of California, San Diego, June 2008
First Received: September 14, 2005   Last Updated: June 20, 2008   History of Changes
Sponsors and Collaborators: University of California, San Diego
National Eye Institute (NEI)
Information provided by: University of California, San Diego
ClinicalTrials.gov Identifier: NCT00221897
  Purpose

A prospective, longitudinal observational cohort study evaluating the relationship between changes in the structure of the eye and the vision loss caused by glaucoma. There are two main parts to the study: 1) Visual Function and 2) Optic Nerve Structure


Condition
Primary Open Angle Glaucoma
Persons at Risk for Glaucoma

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Diagnostic Innovations in Glaucoma Study

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

Study Start Date: April 1995
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 psychophysical and imaging techniques, we will continue use of 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 associated with magnocellular, small bistratified "blue-yellow", and parvocellular neural pathways.
  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
  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.
  4. To determine the quantitative temporal relationships between recognizable optic nerve damage and measurable visual field loss. 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.

SPECIFIC AIMS OF DIGS: STRUCTURAL ASSESSMENT Overall Aim: Develop improved methods to 1) detect the onset and progression of structural damage due to glaucoma, and 2) to measure the rate of glaucomatous progression and its determinants, and 3) characterize the relationship between structural and functional change over time. In addition, a major goal of this research is to develop methods to shorten the time frame needed to identify and verify progression of optic disc and retinal nerve fiber damage.

SPECIFIC AIMS OF DIGS: VISUAL FUNCTION Overall Aim: Develop improved measures to detect the onset and progression of glaucoma, to assess treatment effectiveness, and to validate predictive genetic testing using psychophysical measures of visual function.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 for study to acquire 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 for uncomplicated cataract surgery)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221897

Contacts
Contact: Eunice Williams-Steppe, MA 858-822-1133 ewsteppe@glaucoma.ucsd.edu
Contact: Cecelia Gastelum, MPH 858-534-6714 cgastelum@glaucoma.ucsd.edu

Locations
United States, California
UCSD, Hamilton Glaucoma Center Recruiting
La Jolla, California, United States, 92093-0946
Contact: Eunice Williams-Steppe, MA     858-822-1133     ewsteppe@glaucoma.ucsd.edu    
Contact: Cecelia Gastelum, MPH     858-534-6714     cgastelum@glaucoma.ucsd.edu    
Principal Investigator: Pamela A Sample, PhD            
Principal Investigator: Linda M Zangwill, PhD            
Sub-Investigator: Robert N Weinreb, MD            
Sub-Investigator: Felipe Medeiros, MD            
Sub-Investigator: Christopher Bowd, PhD            
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Pamela A Sample, PhD University of California, San Diego
Principal Investigator: Linda Zangwill, PhD University of California, San Diego
  More Information

Additional Information:
Publications:
Sample PA, Weinreb RN, Boynton RM. Acquired dyschromatopsia in glaucoma. Surv Ophthalmol. 1986 Jul-Aug;31(1):54-64. Review.
Weinreb R.N. and Greve E.L. (Eds.). (2004). Glaucoma diagnosis. Structure and function. The Hague, The Netherlands: Kugler Publications.
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 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 2. In Anderson J.A and Johnson C.A. (eds.). Frequency-Doubling Technology Perminetry (pp. 213-226)
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. (pp. 227 -236).
Zangwill LM, Abunto T, Bowd C, Angeles R, Schanzlin DJ, Weinreb RN. Scanning laser polarimetry retinal nerve fiber layer thickness measurements after LASIK. Ophthalmology. 2005 Feb;112(2):200-7.
Medeiros FA, Zangwill LM, Bowd C, Vessani RM, Susanna R Jr, Weinreb RN. Evaluation of retinal nerve fiber layer, optic nerve head, and macular thickness measurements for glaucoma detection using optical coherence tomography. Am J Ophthalmol. 2005 Jan;139(1):44-55.
Zangwill LM, Chan K, Bowd C, Hao J, Lee TW, Weinreb RN, Sejnowski TJ, Goldbaum MH. Heidelberg retina tomograph measurements of the optic disc and parapapillary retina for detecting glaucoma analyzed by machine learning classifiers. Invest Ophthalmol Vis Sci. 2004 Sep;45(9):3144-51.
Bowd C, Zangwill LM, Medeiros FA, Hao J, Chan K, Lee TW, Sejnowski TJ, Goldbaum MH, Sample PA, Crowston JG, Weinreb RN. Confocal scanning laser ophthalmoscopy classifiers and stereophotograph evaluation for prediction of visual field abnormalities in glaucoma-suspect eyes. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2255-62.
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.
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.
Medeiros FA, Zangwill LM, Bowd C, Weinreb RN. Comparison of the GDx VCC scanning laser polarimeter, HRT II confocal scanning laser ophthalmoscope, and stratus OCT optical coherence tomograph for the detection of glaucoma. Arch Ophthalmol. 2004 Jun;122(6):827-37.
Mohammadi K, Bowd C, Weinreb RN, Medeiros FA, Sample PA, Zangwill LM. Retinal nerve fiber layer thickness measurements with scanning laser polarimetry predict glaucomatous visual field loss. Am J Ophthalmol. 2004 Oct;138(4):592-601.

Study ID Numbers: RO1-EY08208; RO1-EY11008
Study First Received: September 14, 2005
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00221897     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

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

ClinicalTrials.gov processed this record on May 06, 2009