Advanced Glaucoma Progression Study (AGPS)
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| ClinicalTrials.gov Identifier: NCT01742819 |
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Recruitment Status :
Active, not recruiting
First Posted : December 5, 2012
Last Update Posted : October 19, 2021
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| Condition or disease |
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| Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Chronic Angle Closure Glaucoma |
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 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 : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
| Group/Cohort |
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Advanced glaucoma
Patients with MD < -6 or visual field loss within the central 10 degrees of the visual field.
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- 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.
- Worsening of OCT measurements [ Time Frame: 5 Years ]Worsening of macular and retinal nerve fiber layer (RNFL) OCT measurements.
- Contrast sensitivity [ Time Frame: 5 years ]Looking at any changes in contrast sensitivity using the Vector Vision CSV-1000 eye chart.
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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
| United States, California | |
| UCLA Jules Stein Eye Institute | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | Kouros Nouri-Mahdavi, MD, MSc | Jules Stein Eye Institute, UCLA |
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 |
| 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: | October 19, 2021 |
| Last Verified: | October 2021 |
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Glaucoma, Optical Coherence Tomography, Progression |
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Glaucoma Glaucoma, Open-Angle Glaucoma, Angle-Closure Disease Progression |
Ocular Hypertension Eye Diseases Disease Attributes Pathologic Processes |