Diagnostic Innovations in Glaucoma Study

Study acronym: DIGS
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Notable Primary and study completion dates: Jul 2022 to Jul 2030
    • Site contact updated
    v10
  2. Notable Primary and study completion dates: Jul 2020 to Jul 2022v9
  3. Minor Primary completion date: Jul 2020v8 Show 5 more changesShow less
    • Study completion date: Jul 2016 to Jul 2020
    • Eligibility criteria shortened, about 57 words
    • Study description expanded, about 268 words
    • Site contact updated
    • Publications: 36 to 60
  4. Minor Study completion date: Jul 2016v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Site contact updatedv5
  2. Minor Enrollment target: 3000v4
  3. Minor Site contact updatedv3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The overarching goal of our research study is to evaluate changes in visual function and optic nerve topography (the structure of the back of the eye) in patients with glaucoma (increased susceptibility to pressure inside the eye that can cause loss of vision) or those with an increased risk of developing the disease. The purpose of this study is to determine the best methods for detecting the presence or progression (worsening over time) of glaucoma in patients with and without myopia and its effects on daily and visual function and quality of life. With several sources of NIH and foundation funding over the last twenty years we have designed a robust research protocol to address the most challenging aspects of glaucoma management. The most recent focus of this research is 1) to improve our ability to detect open angle glaucoma in individuals with myopia and in individuals of European and African descent, 2) to determine whether monitoring of the retinal vasculature with new optical imaging instruments can improve glaucoma management and elucidate the pathophysiology of the disease, and 3) to differentiate between age-related changes and glaucomatous progression. The grants supporting this project include 3 NIH funded studies, 1) the University of California, San Diego UCSD -based "Diagnostic Innovations in Glaucoma Study" (DIGS funded since 1995): 2) the "African Descent and Glaucoma Evaluation Study" (ADAGES funded since 2002), 3) the Brightfocus Foundation National Glaucoma Research Program and 4) the UCSD-based "Diagnosis and Monitoring of Glaucoma with Optical Coherence Tomography Angiography" (funded since 2018). The ADAGES is a multi-center study with data collection also conducted at 2 other academic sites, the University of Alabama at Birmingham, and Columbia University. Enrolled healthy participants, glaucoma suspects and glaucoma patients are generally asked to return for two or more visits a year for several years. We then analyze whether the glaucoma patients are progressing and what factors influence their glaucoma status compared to healthy subjects and individuals suspected of having glaucoma.
Trial Details
NCT Number NCT00221897
Lead Sponsor University of California, San Diego
Collaborators: National Eye Institute (NEI)
Conditions
(from sponsor)
Primary Open Angle Glaucoma, Myopia
Related terms Glaucoma, Glaucoma, Open-Angle, Myopia
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov