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Diagnostic Innovations in Glaucoma Study (DIGS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by University of California, San Diego.
Recruitment status was:  Recruiting
National Eye Institute (NEI)
Information provided by:
University of California, San Diego Identifier:
First received: September 14, 2005
Last updated: August 29, 2011
Last verified: August 2011
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

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
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00221897

United States, California
UCSD, Hamilton Glaucoma Center
La Jolla, California, United States, 92093-0946
Sponsors and Collaborators
University of California, San Diego
National Eye Institute (NEI)
Principal Investigator: Linda Zangwill, PhD University of California, San Diego
Principal Investigator: Felipe Medeiros, MD University of California, San Diego
  More Information

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).

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Neeraj Agarwal/Program Officer, National Eye Institute Identifier: NCT00221897     History of Changes
Other Study ID Numbers: RO1-EY08208; RO1-EY11008 
Study First Received: September 14, 2005
Last Updated: August 29, 2011

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

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases processed this record on February 20, 2017