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Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension

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ClinicalTrials.gov Identifier: NCT02541994
Recruitment Status : Terminated (Disparate corneal thickness readings from two measurement techniques employed.)
First Posted : September 4, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Lawton, MD, Ochsner Health System

Brief Summary:
Patients in for treatment of benign intracranial hypertension will undergo two tests that are not routinely performed for these patients: central corneal thickness and axial length of the eye. The data obtained from these measurements will be assessed to see if the correlate with aspects of vision loss including visual acuity, visual field status, optical coherence tomography (OCT) results, and fundus photographs.

Condition or disease Intervention/treatment Phase
Benign Intracranial Hypertension Device: Pachette3 Device: Lenstar-Think Not Applicable

Detailed Description:
Patients with benign intracranial hypertension would be identified at diagnosis from the general ophthalmic and neurologic patient population in the Ochsner Health System. All would have a baseline eye examination with visual field and optical coherence tomography (OCT) testing, a standard step in managing any patient with this condition. Two measurements would be taken at minimal risk to the patient that they would not normally have done at the baseline exam: central corneal thickness and axial length. These procedures are routinely done on patients with glaucoma, corneal disease, and cataracts without a significant risk of injury. The theoretical risks with central corneal thickness and axial length measurements by A-scan ultrasonography are related to the small risk for transmission of infection or corneal abrasion due to a probe touching the cornea. These tests would be performed at no charge to the patient and would not significantly increase the time of the ocular examination. Patients would have neuro-imaging studies and lumbar puncture to confirm the diagnosis of benign intracranial hypertension as standard parts of the work up for the condition independent of the research study. The authors will statistically analyze the standard measures of visual field function and health of the nerve fiber layer by OCT to see if any or all of the proposed risk factors correlates with deterioration of visual function. Data would continue to be collected at follow up visits related to visual fields and OCT as would normally be performed on standard visits for this condition. The measurements of central corneal thickness and axial length would be performed solely at the time of enrollment in the study since these measurements do not change over time.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Potential Value of Axial Length and Central Corneal Thickness in the Assessment for Risk of Permanent Optic Nerve Damage and Visual Field Loss in Benign Intracranial Hypertension
Study Start Date : September 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ultrasound Testing
Single arm with all patients getting measurements of axial length and central corneal thickness.
Device: Pachette3
Central corneal thickness will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension.
Other Names:
  • Serial Number 2008-1206
  • Model DGH555

Device: Lenstar-Think
Axial length will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension.
Other Names:
  • Model LS900
  • Serial Number 02114




Primary Outcome Measures :
  1. Axial length [ Time Frame: Single measurement at the time of enrollment in the study. ]
    The length of the eye will be measured with ultrasound.


Secondary Outcome Measures :
  1. Central corneal thickness [ Time Frame: Single measurement at the time of enrollment in the study. ]
    The thickness of the cornea will be measured with ultrasound.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have benign intracranial hypertension.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541994


Sponsors and Collaborators
Ochsner Health System
Investigators
Principal Investigator: Andrew W Lawton, MD Ochsner Health Services

Responsible Party: Andrew Lawton, MD, Physician, Ochsner Health System
ClinicalTrials.gov Identifier: NCT02541994     History of Changes
Other Study ID Numbers: 2015.002.A
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Pseudotumor Cerebri
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases