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Advanced Glaucoma Progression Study (AGPS)

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ClinicalTrials.gov Identifier: NCT01742819
Recruitment Status : Active, not recruiting
First Posted : December 5, 2012
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Kouros Nouri-Mahdavi, University of California, Los Angeles

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Glaucoma is one of the leading causes of blindness in the world. The key to prevention of visual loss from glaucoma is early detection of the disease or its progression and timely treatment. The proposed study will investigate the role of various tests in improving detection of disease progression in advanced glaucoma. Evaluation of the peripheral field of vision (visual field examination) remains the current standard for detection of progression in glaucoma. However, there is a lot of variability or inconsistency in eyes with advanced glaucoma, which could make it difficult to detect worsening of glaucoma with visual fields. The optic nerve demonstrates significant damage in such eyes and hence oftentimes repeat imaging of the optic nerve head is not helpful for detection of change. Therefore, imaging of the central retina (the innermost sensitive tissue lining the inside of the eye), called macula, has been proposed to supplant imaging of the nerve in eyes with severe glaucoma. The macula aids in detailed central vision. Since the macular retinal neural cells are the last ones to be affected in glaucoma, measurement of macular retinal thickness could provide significant information with regard to the course of glaucoma. In the proposed study, glaucoma patients will be tested and followed with various measurements done with newer versions of optical coherence tomography (OCT) imaging and visual field machines. The patients will undergo repeat imaging and visual field testing every 6 months over the course of 5 years. Rates of change will be estimated. We will explore if changes in various outcome measures derived from imaging are correlated with the corresponding visual field changes in glaucoma, and whether the former can be used as an alternative method for detecting simultaneous or subsequent glaucoma progression. The hypothesis for this proposed research is that macular OCT parameters are valid structural measures that can be used especially in advanced disease to follow the course of glaucoma.

Condition or disease
Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Chronic Angle Closure Glaucoma

Detailed Description:

Glaucoma is a major public health issue worldwide and manifests clinically as a chronic progressive optic neuropathy with concomitant visual field (VF) loss. Glaucoma can cause significant visual disability and decreased quality of life (1). Based on WHO's report in 2002, glaucoma is the second cause of blindness. The key to prevention of visual loss from glaucoma is early detection of the disease or its progression and timely treatment. Glaucoma can be quite advanced at the time of initial detection. The prevalence of advanced glaucoma at the time of diagnosis varies but can be quite high. For example, the average VF mean deviation (MD) in patients diagnosed with glaucoma in the Los Angeles Latino Eye Study was −9.6 dB (2), which represents moderately advanced to severe glaucoma. Detection of progression in advanced stages of glaucoma continues to be challenging. Visual field examination remains the gold standard for detection of progression in advanced glaucoma. However, long-term VF variability or noise in such eyes is significant, which could confound detection of change. The optic nerve head and peripapillary retinal nerve fiber layer (RNFL) demonstrate significant damage in such eyes and hence are not helpful for detection of change. About 50% of retinal ganglion cells (RGCs) are located within 4-5 mm of the macular center (3). Since the macular RGCs are the last ones to be affected in glaucoma, measurement of macular retinal thickness or retinal sublayers could provide significant information with regard to the course of advanced glaucoma.

The macular retinal sublayers can now be measured with reasonable accuracy with SD- OCTs. There is some evidence that measurement of the macular ganglion cell complex (GCC, combined thickness of RNFL, RGC and inner plexiform layer or IPL), or macular retinal thickness or volume may detect early glaucoma with a performance that approximates that of circumpapillary RNFL thickness measurements (4,5). In addition, such macular measurements have proved to be very reproducible (4,6). Given this excellent reproducibility, macular outcome measures would be the main candidates for following glaucoma eyes with advanced damage, in which the macular region is essentially the only retinal area with residual RGCs.


Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Glaucoma Progression Study With Macular OCT Imaging
Actual Study Start Date : May 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Advanced glaucoma
Patients with MD < -6 or visual field loss within the central 10 degrees of the visual field.


Outcome Measures
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Primary Outcome Measures :
  1. Visual field progression [ Time Frame: 5 years ]
    Worsening of the MD and/or increased visual field loss within the central 10 degrees of the field.

  2. Worsening of OCT measurements [ Time Frame: 5 Years ]
    Worsening of macular and retinal nerve fiber layer (RNFL) OCT measurements.


Secondary Outcome Measures :
  1. Contrast sensitivity [ Time Frame: 5 years ]
    Looking at any changes in contrast sensitivity using the Vector Vision CSV-1000 eye chart.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced glaucoma patients
Criteria

Inclusion Criteria:

  • Clinical diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, and angle closure glaucoma
  • Visual field MD of -6dB or worse OR visual field loss involvement at at least two points within the central 10 degrees of the field

Exclusion Criteria:

  • Patient not within the ages of 40-80 years old
  • Visual acuity worse than 20/50 at baseline
  • Spherical refraction worse than 8D and cylindrical refraction worse than 3D
  • Significant retinal or neurological diseases including diabetic retinopathy or age-related macular degeneration
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742819


Locations
United States, California
UCLA Jules Stein Eye Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Eye Institute (NEI)
Investigators
Principal Investigator: Kouros Nouri-Mahdavi, MD, MSc Jules Stein Eye Institute, UCLA
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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

Responsible Party: Kouros Nouri-Mahdavi, Assistant Professor of Ophthalmology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01742819     History of Changes
Other Study ID Numbers: IRB# 11-003602
1K23EY022659-01 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Keywords provided by Kouros Nouri-Mahdavi, University of California, Los Angeles:
Glaucoma, Optical Coherence Tomography, Progression

Additional relevant MeSH terms:
Glaucoma
Disease Progression
Glaucoma, Open-Angle
Glaucoma, Angle-Closure
 Ocular Hypertension
Eye Diseases
Disease Attributes
Pathologic Processes