Macular Damage in Early Glaucoma and Progression

Therapuetic Areas:Ophthalmology
Age Range:18 - 85
Start Date:October 2015
End Date:December 2019
Contact:Lam Lu, BS

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Structural and Functional Progression of Glaucomatous Damage to the Macula

Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a
new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is
getting worse. There is scientific evidence that the macula, the central part of the retina,
can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very
prevalent and is often missed using conventional clinical tests.

Relatively little is known about progression of early glaucoma damage and its effects on the
macula. This project investigates the nature of progressive damage to the macula and proposes
new methods to improve accuracy to detect clinically significant progression.The study will
evaluate the nature of damage to the macula's structures through OCT imaging and eye function
via visual field tests.

There is compelling evidence that glaucomatous damage to the macula occurs even in early
stages of the disease. The macula comprises about 30% of all retinal ganglion cells and its
information corresponds to over 50% of the visual cortex. However, glaucomatous damage to the
macula is often missed in clinical practice. Some of the reasons are:

1. traditional glaucoma knowledge supports that glaucoma is fundamentally a peripheral

2. inherent limitations of conventional clinical tests to detect damage to the macula; and

3. the paucity of large, prospective studies that describe the nature of glaucomatous
damage to the macula.

The investigators have published numerous papers in the past two years showing that macular
damage is prevalent among patients with early glaucoma if one employs the appropriate tools
to assess it, namely 10-2 visual fields and high-resolution optical coherence tomography
(OCT). This information comes from a unique prospective cross- sectional database and
techniques the investigators developed to produce objective metrics of structure and

Now that the investigators understand the cross-sectional nature of macular damage, this
proposal aims to:

1. develop a longitudinal database including patients with early glaucoma and healthy

2. to test models that explain progression of macular damage, and

3. to apply new statistical methods combining structural and functional tests which could
improve the accuracy to detect progression and shorten the length of clinical trials.

The main hypothesis is that incorporating 10-2 visual field testing and high-resolution OCT
scans of the macula to the conventional repertoire of technologies used in clinical practice,
in addition to translating recently described statistical methods into softwares that can be
used in daily practice, enhances the performance and confidence to detect glaucoma

In Aim 1 the investigators plan to follow healthy subjects and glaucoma patients at regular
intervals with 10-2, 24-2 visual fields, and swept source (ss) OCT tests and define metrics
of short- and long-term test variability that are needed to differentiate true progression
from 'noise'. To date, there is no such database combining these technologies.

In Aim 2 the investigators plan to combine metrics of structure and function from this
longitudinal database using two methods: a spatial approach, which will ultimately produce a
joint structure-function index using 10-2 and ssOCT data; and a temporal approach, which will
employ Bayesian statistics to measure rates of progression using trend analysis. By the end
of the study, our contributions to the field should be:

1. to make available a unique and pristine longitudinal database that could be used for
other hypotheses testing,

2. to translate techniques recently described in the literature into objective tools to be
readily useful in clinical practice, and

3. to mitigate the burdens of progressive loss of central vision in glaucoma.

Glaucoma Group:

Inclusion Criteria:

- glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology
Preferred Practice Pattern criteria)

Exclusion Criteria:

- late functional glaucomatous damage

- significant cataract

- previous ocular surgery (aside from uncomplicated cataract extraction with intraocular
lens (IOL) implantation and/or trabeculectomy, LASIK or refractive surgeries)

- diabetic retinopathy with macular edema

- vein or artery occlusion

- exudative age-related macular degeneration or geographic atrophy

- macular hole or traction

- amblyopia

- uveitis

- non-open angle glaucoma (e.g. angle closure, traumatic, congenital glaucoma)

- severe myopia or hyperopia (refractive error greater than -6 or +6D, respectively)

- retinal detachment (current or post-surgery)

- retinitis pigmentosa

- significant epiretinal memberane

- significant kerotoconus

Healthy Group:

Inclusion Criteria:

- best corrected visual acuity equal or better than 20/40

- normal biomicroscopy examination

- gonioscopically open angles

- Intraocular Pressure (IOP) lower than 22 mmHg

- normal and reliable 24-2 and 10-2 SAP results

Exclusion Criteria:

- evidence of optic neuropathy

- evidence of clinically significant metabolic diseases (e.g. diabetes and hypotension)
We found this trial at
New York, New York 10032
Phone: 646-457-0940
New York, NY
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