Healia Clinical Trials Information Database

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

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.

Status: Recruiting (N/A). Started on April 1st, 1995.

Enrollment: 3000 subjects

Study Type: Observational

Study Design:

  • Observational Model: Cohort
  • Time Perspective: Prospective

Conditions:

Interventions:


Eligibility

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.

Gender

Both

Mininum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: University of California, San Diego

Authority: United States: Institutional Review Board

Locations

  • UCSD, Hamilton Glaucoma Center
    La Jolla
    California
    92093-0946
    United States

Officials

  • Linda Zangwill, PhD (Principal Investigator, University of California, San Diego)

  • Felipe Medeiros, MD (Principal Investigator, University of California, San Diego)

Sponsors

  • University of California, San Diego (Lead Sponsor)

  • National Eye Institute (NEI) (Collaborator)

References

None.

Links


Date Verified
August 1st, 2011
First Received
August 29th, 2011
Last Changed
August 29th, 2011

Information obtained from ClinicalTrials.gov on August 29, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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