Advanced Glaucoma Progression Study



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:40 - 80
Updated:2/14/2018
Start Date:May 2012
End Date:August 2018

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Detection of Glaucoma Progression Study With Macular OCT Imaging

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.

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.

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
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Los Angeles, California 90095
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