Clinical Trial: Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational
Official Title: Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure
Brief Summary: 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.
Detailed Summary:
Objective:
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).
Specific Aims:
In this study, the investigators 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. The investigators will apply controlled pressures to the eye during each step of ICP lowering while OCT images are obtained.
Background:
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.
The ONH separates two pressurized compartments: the eyeball and the central nervous system. Situations in which ICP is elevated are often associated with papilledema, though the magnitude and the rate of change in ONH elevation in response to increased ICP or the reduction in ONH elevation in response to ICP treatments are yet to be determined. On the opposite side, glaucoma is a leading cause of blindness where elevated IOP is the leading risk factor, with clinical evidence suggesting the presence of ICP below the normal level in these subjects. The impaired balance between IOP and ICP leads to the deformation of the ONH, which triggers strangulation of the retinal ganglion cell axons when trespassi
Sponsor: New York University School of Medicine
Current Primary Outcome: Optic Nerve Head [ Time Frame: 1 Week ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: New York University School of Medicine
Dates:
Date Received: September 22, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: January 11, 2017
Last Verified: January 2017
