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Primary Open Angle GlaucomaDIGSNCT00221897

Diagnostic Innovations in Glaucoma Study

An observational study of Primary Open Angle Glaucoma and Myopia, run by University of California, San Diego at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Primary Open Angle Glaucoma, Myopia
How many people
3,000 participants
Where
1 siteUnited States
Study dates
Apr 1995to Jul 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults

Who may be able to join

  • Subjects are healthy controls with or without myopia, and patients with or without myopia with a diagnosis of glaucoma, glaucoma suspect and ocular hypertension
  • They will be considered if they are above 18 years old.
  • There is no upper age limit
  • Subject are not restricted by gender, race or ethnicity.

Who cannot join

  • -Participants with other ocular or systemic conditions and treatment, which may affect visual function, are excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Veronica Inpirom contact

858-822-4669

vrubio@health.ucsd.edu

United States1 site, 1 recruiting
  • UCSD, Hamilton Glaucoma Center

    La Jolla, California, 92093-0946

    Veronica Inpirom, 858-822-4669, vrubio@health.ucsd.edu

    Linda M Zangwill, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

The Diagnostic Innovation in Glaucoma Study (DIGS) and ADAGES are longitudinal studies in which participants with or without myopia are examined approximately biannually, in most cases. Healthy controls with or without myopia are examined once, in most cases. The ADAGES recruitment and testing of individuals of African descent is an independently funded multi-center (including UCSD, Columbia University, and University of Alabama, Birmingham) study, which follows the same study protocol as the DIGS to ensure that the data from both studies can be analyzed together. This harmonization of protocols leverages the advantages of both DIGS by increasing the sample sizes to address the unique hypotheses of each study.

All participants must be 18 years old or older. Participants with or without myopia will be required to have at least one eye with open angles, best corrected visual acuity of 20/40 or better to be included. Participants taking a medication known to affect visual field sensitivity and eyes with a history of intraocular surgery (except uncomplicated glaucoma and cataract surgery), a secondary cause of elevated intraocular pressure, a coexisting intraocular disease affecting visual field, or a problem other than glaucoma affecting color vision may be excluded.

Most of the extensive testing completed for these visits can be considered standard of care, but for clinical care all tests are not generally all done at the same patient visit with the variety of instruments included in this research project. The following tests can be considered standard of care: medical history, blood pressure and heart rate, height and weight, visual acuity testing near acuity testing, low contrast sensitivity testing, slit lamp biomicroscopy (including gonioscopy), measurements of intraocular pressure with contact and non-contact tonometry, corneal thickness measurement (pachymetry), corneal elasticity measured using non-contact tonometry, interocular axial length, corneal curvature, anterior chamber depth measurements (all measured using intraocular lens IOL master), dilated fundoscopy, stereoscopic ophthalmoscopy of the optic disc with a 78 D lens, color vision testing, standard automated perimetry, optical coherence tomography (OCT) and photography.

There is currently no end date to the study, as the follow-up will continue as long as the research is supported.

The time involved is usually 2-4 visits per year of approximately 2-5 hours each.

DIGS Positional Study Subjects will also be given the opportunity to participate in the following additional auxiliary study. The DIGS Positional Study will allow subjects to participate in an ancillary study. Participation in this ancillary study includes imaging of the eyes using Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCT-A), as well as measurement of intraocular pressure (IOP) and blood pressure (BP) in sitting and supine positions. No invasive procedures or treatments will be administered. We will be using the standard clinically available software as well as investigational software available for research purposes. The investigational software has been deemed safe by the manufacturer of the device and does not pose any additional risks to patients. Since not every glaucoma patient has high eye pressure (low-tension glaucoma) or has pressure controlled with medication use (so that the untreated eye pressure is now known), glaucoma subjects using intraocular pressure lowering medication and with IOP < 25 mm Hg may be requested to stop their medication for 1 to 3 weeks, by the treating ophthalmologist depending on the class of medication, before being imaged. Risks are small and include IOP elevation. However, glaucoma progression is on the order of months to years, and not days. Subjects will resume using the medication after the research visit is completed.

Keywords
Primary open angle glaucoma, Glaucoma/pathology, Glaucoma/physiopathology, Nerve Fibers/pathology, Risk factors glaucoma
Medical subject headings
Glaucoma, Open-Angle, Myopia, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00221897
Study groupRoleWhat they receive
Healthy individualshealthy controls with or without myopia
Persons at risk for or with primary open angle glaucomawith or without myopia with a diagnosis of glaucoma, glaucoma suspect and ocular hypertension

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startApr 1995
  3. Primary completionJul 2030 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00221897
Sponsor's protocol ID
EY08208; EY11008, EY027510
Other IDs
R01EY027510
Acronym
DIGS
Status last verified
Oct 2025
First submitted
14 Sep 2005
Last updated
24 Oct 2025
Results posted
No
Data monitoring committee
No

Publications

  • Sample PA, Weinreb RN, Boynton RM. Acquired dyschromatopsia in glaucoma. Surv Ophthalmol. 1986 Jul-Aug;31(1):54-64. doi: 10.1016/0039-6257(86)90051-2.

    PubMed 3529468
  • Weinreb R.N. and Greve E.L. (Eds.). (2004). Glaucoma diagnosis. Structure and function. The Hague, The Netherlands: Kugler Publications.

  • Anderson DR. Standard perimetry. Ophthalmol Clin North Am. 2003 Jun;16(2):205-12, vi. doi: 10.1016/s0896-1549(03)00005-1.

    PubMed 12809158
  • 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)

  • Racette L, Sample PA. Short-wavelength automated perimetry. Ophthalmol Clin North Am. 2003 Jun;16(2):227-36, vi-vii. doi: 10.1016/s0896-1549(03)00010-5.

    PubMed 12809160
  • Zangwill LM, Abunto T, Bowd C, Angeles R, Schanzlin DJ, Weinreb RN. Scanning laser polarimetry retinal nerve fiber layer thickness measurements after LASIK. Ophthalmology. 2005 Feb;112(2):200-7. doi: 10.1016/j.ophtha.2004.08.019.

    PubMed 15691551
  • Medeiros FA, Zangwill LM, Bowd C, Vessani RM, Susanna R Jr, Weinreb RN. Evaluation of retinal nerve fiber layer, optic nerve head, and macular thickness measurements for glaucoma detection using optical coherence tomography. Am J Ophthalmol. 2005 Jan;139(1):44-55. doi: 10.1016/j.ajo.2004.08.069.

    PubMed 15652827
  • Zangwill LM, Chan K, Bowd C, Hao J, Lee TW, Weinreb RN, Sejnowski TJ, Goldbaum MH. Heidelberg retina tomograph measurements of the optic disc and parapapillary retina for detecting glaucoma analyzed by machine learning classifiers. Invest Ophthalmol Vis Sci. 2004 Sep;45(9):3144-51. doi: 10.1167/iovs.04-0202.

    PubMed 15326133
  • Bowd C, Zangwill LM, Medeiros FA, Hao J, Chan K, Lee TW, Sejnowski TJ, Goldbaum MH, Sample PA, Crowston JG, Weinreb RN. Confocal scanning laser ophthalmoscopy classifiers and stereophotograph evaluation for prediction of visual field abnormalities in glaucoma-suspect eyes. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2255-62. doi: 10.1167/iovs.03-1087.

    PubMed 15223803
  • Sample PA, Chan K, Boden C, Lee TW, Blumenthal EZ, Weinreb RN, Bernd A, Pascual J, Hao J, Sejnowski T, Goldbaum MH. Using unsupervised learning with variational bayesian mixture of factor analysis to identify patterns of glaucomatous visual field defects. Invest Ophthalmol Vis Sci. 2004 Aug;45(8):2596-605. doi: 10.1167/iovs.03-0343.

    PubMed 15277482
  • Medeiros FA, Sample PA, Weinreb RN. Frequency doubling technology perimetry abnormalities as predictors of glaucomatous visual field loss. Am J Ophthalmol. 2004 May;137(5):863-71. doi: 10.1016/j.ajo.2003.12.009.

    PubMed 15126151
  • Medeiros FA, Zangwill LM, Bowd C, Weinreb RN. Comparison of the GDx VCC scanning laser polarimeter, HRT II confocal scanning laser ophthalmoscope, and stratus OCT optical coherence tomograph for the detection of glaucoma. Arch Ophthalmol. 2004 Jun;122(6):827-37. doi: 10.1001/archopht.122.6.827.

    PubMed 15197057
  • Mohammadi K, Bowd C, Weinreb RN, Medeiros FA, Sample PA, Zangwill LM. Retinal nerve fiber layer thickness measurements with scanning laser polarimetry predict glaucomatous visual field loss. Am J Ophthalmol. 2004 Oct;138(4):592-601. doi: 10.1016/j.ajo.2004.05.072.

    PubMed 15488786
  • Belghith A, Medeiros FA, Bowd C, Liebmann JM, Girkin CA, Weinreb RN, Zangwill LM. Structural Change Can Be Detected in Advanced-Glaucoma Eyes. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT511-8. doi: 10.1167/iovs.15-18929.

    PubMed 27454660
  • Diniz-Filho A, Abe RY, Zangwill LM, Gracitelli CP, Weinreb RN, Girkin CA, Liebmann JM, Medeiros FA. Association between Intraocular Pressure and Rates of Retinal Nerve Fiber Layer Loss Measured by Optical Coherence Tomography. Ophthalmology. 2016 Oct;123(10):2058-65. doi: 10.1016/j.ophtha.2016.07.006. Epub 2016 Aug 20.

    PubMed 27554036

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Open Angle Glaucoma and Myopia, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Veronica Inpirom (858-822-4669, vrubio@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00221897, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.

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Diagnostic Innovations in Glaucoma Study (NCT00221897) | AzTrials