Diagnostic Innovations in Glaucoma Study (DIGS)

This study is currently recruiting participants.
Verified August 2011 by University of California, San Diego
Sponsor:
Collaborator:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00221897
First received: September 14, 2005
Last updated: August 29, 2011
Last verified: August 2011
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Innovations in Glaucoma Study

Resource links provided by NLM:


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

Estimated Enrollment: 3000
Study Start Date: April 1995
Estimated Study Completion Date: July 2016
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 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
Sampling Method:   Non-Probability Sample
Study Population

Adults

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: Cheryl Rudy-Goodness, MPH 858-822-1896 cgoodness@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: Linda M Zangwill, PhD         
Sub-Investigator: Robert N Weinreb, MD         
Principal Investigator: Felipe Medeiros, MD         
Sub-Investigator: Christopher Bowd, PhD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Linda Zangwill, PhD University of California, San Diego
Principal Investigator: Felipe Medeiros, MD University of California, San Diego
  More Information

Additional Information:
Publications:
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).

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

Responsible Party: Neeraj Agarwal/Program Officer, National Eye Institute
ClinicalTrials.gov Identifier: NCT00221897     History of Changes
Other Study ID Numbers: RO1-EY08208; RO1-EY11008
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
Glaucoma/pathology
Glaucoma/physiopathology
Nerve Fibers/pathology
Risk factors glaucoma

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

ClinicalTrials.gov processed this record on April 15, 2014