- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541994
Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension
February 9, 2024 updated by: Andrew Lawton, MD, Ochsner Health System
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
5
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients must have benign intracranial hypertension.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Ultrasound Testing
Single arm with all patients getting measurements of axial length and central corneal thickness.
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axial Length
Time Frame: Single measurement during ultrasound procedure on the day of enrollment in the study on average of 5 minutes.
|
The length of the eye will be measured with ultrasound.
|
Single measurement during ultrasound procedure on the day of enrollment in the study on average of 5 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central Corneal Thickness
Time Frame: Single measurement during ultrasound procedure at the time of enrollment in the study on average of 5 minutes.
|
The thickness of the cornea will be measured with ultrasound.
|
Single measurement during ultrasound procedure at the time of enrollment in the study on average of 5 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew W Lawton, MD, Ochsner Health Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
August 25, 2015
First Submitted That Met QC Criteria
September 2, 2015
First Posted (Estimated)
September 4, 2015
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
February 9, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015.002.A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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