Intraocular Pressure Clinical Trial
Official title:
Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure
The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial pressures (ICP) on the optic nerve head (ONH). The effect of ICP on eye health has been an area of concrete research effort in recent years. The ability to acquire non-invasive and highly detailed information on both the eye and the brain using technologies such as magnetic resonance imaging (MRI) and optical coherence tomography (OCT) have paved the way to assess non-invasively the effect of ICP in-vivo. In this study, we will quantify the structural changes in the ONH in subjects with elevated ICP while they are treated to reduce the elevated pressure. This process will occur in a stepwise fashion over a period of time determined by the clinical treatment plans. We will apply controlled pressures to the eye during each step of ICP lowering while OCT images are obtained.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 and older. - Patients with an external ventricular drain (EVD). - Normally appearing eye as determined during the screening clinical examination. Exclusion Criteria: - History of intraocular surgery or ocular trauma (with the exception of laser procedures or uneventful cataract surgery more than 1 year from enrollment date). - Ocular disorders that could affect retinal function such as retinal detachment, diabetic retinopathy, Macular degeneration. - Neurological & Non-Glaucomatous causes for Visual Field damage. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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New York University School of Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optic Nerve Head | The optic nerve head (ONH) structures will be evaluated for tissue deformation. The association between the structural findings in the optic nerve head region and intracranial and intraocular pressures will be evaluated. | 1 Week | No |
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