Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure

NCT ID: NCT02558309

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-10-31

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 Description

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 trespassing through the lamina cribrosa within the ONH on their way from the eye to the brain, leading to gradual axonal loss and irreversible visual impairment.

Significance:

Little is known about how the interaction of IOP and ICP pressure changes affect the macrostructure and microstructure of the optic nerve head structure. This information has a significant impact both for neurosurgical conditions with elevated ICP along with ocular conditions such as glaucoma and papilledema. The ability to gauge non-invasively changes in ICP will have a tremendous impact on neurosurgical management as it eliminates the need of longitudinal invasive measurements of ICP. The study will also improve the investigator's understanding of the pathophysiologic processes that lead to development of glaucoma as well as the response to treatment for subjects with papilledema. A better understanding of these processes will ultimately lead to improved detection and management of these conditions and a better understanding of ocular bio-mechanics.

Conditions

Intraocular Pressure; Intracranial Hypertension

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Intracranial Pressure Reduction

Subjects scheduled to undergo gradual, step-wise reduction of Intracranial Pressure (ICP) will be screened.

• The Glasgow Coma Scale will be administered to ascertain the cognitive ability of the participant.
• A slit lamp examination and indirect ophthalmoscopy will be performed.

Experimental:

• The subject's eye will be held open with an eye speculum during the exam.
• Another eye exam, which includes a slit lamp examination and indirect ophthalmoscopy, will be performed.
• Intraocular Pressure will be measured.
• An Optic Coherence Tomography (OCT) will be performed.
• At each step along the process of ICP reduction, the eye exam, IOP & OCT will be performed.

Optional:

• The Ophthalmology study team will raise the IOP using an Ophthlmodynanometer. It will be raised to 20 mmHg and 40 mmHg while OCT scans are obtained.
• OCT scans will be taken at pre-manipulation, 20mmHg, 40mmHg, and post-manipulation at each step of the ICP lowering procedure.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gadi Wollstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Other Identifiers

PRO15070113

Identifier Type: -

Identifier Source: org_study_id