Benign Intracranial Hypertension
Conditions
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.
Interventions
DEVICEPachette3
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.
DEVICELenstar-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.
Sponsors
Ochsner Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have benign intracranial hypertension.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial Length | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Corneal Thickness | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrasound Testing Single arm with all patients getting measurements of axial length and central corneal thickness.
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.
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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Ultrasound Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 35.6 years STANDARD_DEVIATION 7.92 |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Axial Length
The length of the eye will be measured with ultrasound.
Time frame: Single measurement during ultrasound procedure on the day of enrollment in the study on average of 5 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Testing | Axial Length | 23.67 millimeter | Standard Deviation 1.31 |
Secondary
Central Corneal Thickness
The thickness of the cornea will be measured with ultrasound.
Time frame: Single measurement during ultrasound procedure at the time of enrollment in the study on average of 5 minutes.
Population: 10 eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Testing | Central Corneal Thickness | 556.3 Microns | Standard Deviation 26.9 |