Benign Intracranial HypertensionNCT02541994
Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension
A study testing Pachette3 and Lenstar-Think in people with Benign Intracranial Hypertension, run by Ochsner Health System.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Intracranial Hypertension
- What is being tested?
- Pachette3 and Lenstar-Think
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have benign intracranial hypertension.
Who cannot join
- None
About this study
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
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.
Read the 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.
- Conditions
- Benign Intracranial Hypertension
- Being tested
- Pachette3, Lenstar-Think
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pachette3Device
Also called Serial Number 2008-1206, Model DGH555
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-ThinkDevice
Also called Model LS900, Serial Number 02114
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Testing | Other | Single arm with all patients getting measurements of axial length and central corneal thickness. Receives: Device: Pachette3; Device: Lenstar-Think |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length
The length of the eye will be measured with ultrasound.
Measured: Single measurement during ultrasound procedure on the day of enrollment in the study on average of 5 minutes.
Secondary outcomes (1)
Central Corneal Thickness
The thickness of the cornea will be measured with ultrasound.
Measured: Single measurement during ultrasound procedure at the time of enrollment in the study on average of 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016
- Study completionSep 2017
Why it stopped: Disparate corneal thickness readings from two measurement techniques employed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Lawton, MD, Ochsner Health System
- Investigators
- Andrew W Lawton, MD, Principal investigator, Ochsner Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541994
- Sponsor's protocol ID
- 2015.002.A
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2015
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02541994
- Acronym / sponsor ID
- 2015.002.A
- Conditions
- Benign Intracranial Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Disparate corneal thickness readings from two measurement techniques employed.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Testing | Other | Device: Pachette3, Device: Lenstar-ThinkSingle arm with all patients getting measurements of axial length and central corneal thickness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have benign intracranial hypertension.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pachette3Also: Serial Number 2008-1206, Model DGH555Central 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. | Device | Ultrasound Testing |
| Lenstar-ThinkAlso: Model LS900, Serial Number 02114Axial 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. | Device | Ultrasound Testing |
Primary outcome
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.
1 secondary outcome
Central Corneal Thickness
Time frame: Single measurement during ultrasound procedure at the time of enrollment in the study on average of 5 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Benign Intracranial Hypertension
RecruitingObservational study
Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
Benign Intracranial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew W Lawton, MD principal investigator
Ochsner Health Services
Questions about this trial
What is this clinical trial studying?
A study testing Pachette3 and Lenstar-Think in people with Benign Intracranial Hypertension, run by Ochsner Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial Length (time frame: Single measurement during ultrasound procedure on the day of enrollment in the study on average of 5 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.