Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension

NCT02541994 | Terminated Results

• 1 other identifier: 2015.002.A
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Benign Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

• Axial Length

  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 Outcomes (1)

• Central Corneal Thickness

  Single measurement during ultrasound procedure at the time of enrollment in the study on average of 5 minutes.

Study Arms (1)

Ultrasound Testing

OTHER

Single arm with all patients getting measurements of axial length and central corneal thickness.

Device: Pachette3; Device: Lenstar-Think

Interventions

Pachette3 DEVICE

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.

Also known as: Serial Number 2008-1206, Model DGH555

Ultrasound Testing

Lenstar-Think DEVICE

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.

Also known as: Model LS900, Serial Number 02114

Ultrasound Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have benign intracranial hypertension.

You may not qualify if:

• None

Sponsors & Collaborators

• Ochsner Health System: lead

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Andrew Lawton
• Organization: Ochsner Health Services

andrew.lawton@ochsner.org

504-842-3995

Study Officials

• Andrew W Lawton, MD

  Ochsner Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 4, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: September 1, 2017
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-02