NCT02828891

Brief Summary

This is a single center, prospective study to calculate cerebrospinal fluid pressure (CSFp) using a non-invasive device and assess its role in the development of optic neuropathy due to glaucoma or idiopathic intracranial hypertension (IIH). The study also aims to assess whether CSFp differs between untreated and treated patients with glaucoma, ocular hypertension, IIH, and other ocular diseases that may be associated with CSFp differences.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

2.4 years

First QC Date

July 1, 2016

Last Update Submit

October 28, 2020

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean CSFp for all groups and controls at various time points (e.g., prior to and after medical or surgical intervention) in order to assess for significant differences.

    CSF pressure

    The investigators anticipate to enroll the subjects over a period of 12 months. The estimated time required for data analysis is 6 months following enrollment of all subjects.

Secondary Outcomes (1)

  • Translaminar pressure gradient (calculated as IOP - CSFp) for all groups and controls at various time points (e.g., prior to and after medical or surgical intervention) in order to assess for significant differences.

    The investigators anticipate to enroll the subjects over a period of 12 months. The estimated time required for data analysis is 6 months following enrollment of all subjects.

Study Arms (1)

Experimental

EXPERIMENTAL

Intervention: transcranial Doppler device will be utilized to measure CSF pressure.

Device: Two-Dimensional Transcranial Doppler

Interventions

Two-Dimensional Transcranial DopplerDEVICE

Transcranial Doppler will be used to measure CSF pressure.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Open angle with normal structures on gonioscopy
  • Patients with a diagnosis of, or at risk for the development of, optic neuropathy, including NTG, POAG, OHTN, IIH (in addition to controls)

You may not qualify if:

  • Known abnormal vascular anatomy (i.e., abnormal anatomy of the ophthalmic artery)
  • Alzheimer's disease or other neurodegenerative diseases
  • Known abnormal intracranial anatomy or malformations
  • Minors, prisoners, pregnant patients
  • Patients unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Berdahl JP, Fautsch MP, Stinnett SS, Allingham RR. Intracranial pressure in primary open angle glaucoma, normal tension glaucoma, and ocular hypertension: a case-control study. Invest Ophthalmol Vis Sci. 2008 Dec;49(12):5412-8. doi: 10.1167/iovs.08-2228. Epub 2008 Aug 21.

    PMID: 18719086BACKGROUND

  • Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma. Ophthalmology. 2008 May;115(5):763-8. doi: 10.1016/j.ophtha.2008.01.013.

    PMID: 18452762BACKGROUND

  • Ren R, Jonas JB, Tian G, Zhen Y, Ma K, Li S, Wang H, Li B, Zhang X, Wang N. Cerebrospinal fluid pressure in glaucoma: a prospective study. Ophthalmology. 2010 Feb;117(2):259-66. doi: 10.1016/j.ophtha.2009.06.058. Epub 2009 Dec 6.

    PMID: 19969367BACKGROUND

  • Ren R, Zhang X, Wang N, Li B, Tian G, Jonas JB. Cerebrospinal fluid pressure in ocular hypertension. Acta Ophthalmol. 2011 Mar;89(2):e142-8. doi: 10.1111/j.1755-3768.2010.02015.x.

    PMID: 21348961BACKGROUND

  • Ragauskas A, Matijosaitis V, Zakelis R, Petrikonis K, Rastenyte D, Piper I, Daubaris G. Clinical assessment of noninvasive intracranial pressure absolute value measurement method. Neurology. 2012 May 22;78(21):1684-91. doi: 10.1212/WNL.0b013e3182574f50. Epub 2012 May 9.

    PMID: 22573638BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology, Cell Biology and Neuroscience

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 12, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 30, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share