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
About this trial
This is an interventional screening trial for Benign Intracranial Hypertension
Eligibility Criteria
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
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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