Diagnostic Innovations in Glaucoma Study (DIGS)

This study is currently recruiting participants. (see Contacts and Locations)
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

September 14, 2005
August 29, 2011
April 1995
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00221897 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Diagnostic Innovations in Glaucoma Study
Diagnostic Innovations in Glaucoma Study

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adults

Primary Open Angle Glaucoma
Not Provided
  • Healthy individuals
  • Persons at risk for or with primary open angle glaucoma

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
July 2016
Not Provided

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.
Both
18 Years and older
Yes
Contact: Eunice Williams-Steppe, MA 858-822-1133 ewsteppe@glaucoma.ucsd.edu
Contact: Cheryl Rudy-Goodness, MPH 858-822-1896 cgoodness@glaucoma.ucsd.edu
United States
 
NCT00221897
RO1-EY08208; RO1-EY11008
No
Neeraj Agarwal/Program Officer, National Eye Institute
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
University of California, San Diego
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP