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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

Tracking Information
First Submitted Date  ICMJE August 25, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date April 4, 2018
Study Start Date  ICMJE September 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
Axial length [ Time Frame: Single measurement at the time of enrollment in the study. ]
The length of the eye will be measured with ultrasound.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Benign Intracranial Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE Ultrasound Testing
Single arm with all patients getting measurements of axial length and central corneal thickness.
Interventions:
  • Device: Pachette3
  • Device: Lenstar-Think
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 27, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2015)
50
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have benign intracranial hypertension.

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02541994
Other Study ID Numbers  ICMJE 2015.002.A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Lawton, MD, Ochsner Health System
Study Sponsor  ICMJE Ochsner Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew W Lawton, MD Ochsner Health Services
PRS Account Ochsner Health System
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP