- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02558309
Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure
Study Overview
Status
Conditions
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.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Intracranial Pressure Reduction
Subjects scheduled to undergo gradual, step-wise reduction of Intracranial Pressure (ICP) will be screened.
Experimental:
Optional:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optic Nerve Head
Time Frame: 1 Week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gadi Wollstein, MD, University of Pittsburgh Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO15070113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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