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Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension

Primary Purpose

Benign Intracranial Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pachette3
Lenstar-Think
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Benign Intracranial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have benign intracranial hypertension.

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Ultrasound Testing

    Arm Description

    Single arm with all patients getting measurements of axial length and central corneal thickness.

    Outcomes

    Primary Outcome Measures

    Axial length
    The length of the eye will be measured with ultrasound.

    Secondary Outcome Measures

    Central corneal thickness
    The thickness of the cornea will be measured with ultrasound.

    Full Information

    First Posted
    August 25, 2015
    Last Updated
    April 3, 2018
    Sponsor
    Ochsner Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02541994
    Brief Title
    Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Disparate corneal thickness readings from two measurement techniques employed.
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ochsner Health System

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Intracranial Hypertension

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound Testing
    Arm Type
    Other
    Arm Description
    Single arm with all patients getting measurements of axial length and central corneal thickness.
    Intervention Type
    Device
    Intervention Name(s)
    Pachette3
    Other Intervention Name(s)
    Serial Number 2008-1206, Model DGH555
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Lenstar-Think
    Other Intervention Name(s)
    Model LS900, Serial Number 02114
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Axial length
    Description
    The length of the eye will be measured with ultrasound.
    Time Frame
    Single measurement at the time of enrollment in the study.
    Secondary Outcome Measure Information:
    Title
    Central corneal thickness
    Description
    The thickness of the cornea will be measured with ultrasound.
    Time Frame
    Single measurement at the time of enrollment in the study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have benign intracranial hypertension. Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew W Lawton, MD
    Organizational Affiliation
    Ochsner Health Services
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension

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