Diagnostic Accuracy of the Optic Nerve Deformability Index and Optic Nerve Sheath Diameter as a Noninvasive Predictor of Intracranial Pressure
Launched by BENHA UNIVERSITY · Mar 13, 2025
Trial Information
Current as of May 09, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating two methods for measuring pressure inside the skull, known as intracranial pressure (ICP). Increased ICP can happen due to conditions like traumatic brain injury or bleeding in the brain, and it can be very serious. The study will include 50 patients, who will be divided into two groups: those with high ICP and those with normal levels. Researchers will use two specific tests, the Optic Nerve Sheath Diameter (ONSD) and the Optic Nerve Deformability Index (DI), to see if they can accurately predict ICP without needing invasive procedures.
To be eligible for this trial, participants must be between 18 and 65 years old and have increased ICP due to conditions like traumatic brain injury. They should also have a Glasgow Coma Scale score between 3 and 12, indicating a need for ICP monitoring. However, individuals with certain conditions, such as chronic brain issues or severe eye injuries, cannot participate. If enrolled, participants can expect to undergo non-invasive tests to measure their optic nerve and help doctors understand their intracranial pressure better. This research could lead to safer and easier ways to monitor ICP in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • age 18 to 65 years
- • increased ICP (e.g., TBI, sub arachnoid hemorrhage, intracranial hemorrhage)
- • a Glasgow Coma scale=3-12 and requiring ICP monitoring via invasive methods (e.g. extra ventricular drain, lumber drain)
- Exclusion Criteria:
- • chronic hydrocephalus
- • extensive local orbit trauma
- • a pre-existing ocular disease affecting the optic nerve and/or orbital cavity
- • hyperthyroidism with exophthalmia
- • facial trauma affecting the orbits and/or eyeballs
- • optic nerve trauma
- • signs of critically raised ICP, needing urgent surgery.
- • hemodynamically unstable between ONSD acquisition and ICP measurement.
- • receiving medication that would decrease ICP between ultrasound imaging and ICP measurement, i.e. mannitol, hypertonic saline or steroids.
About Benha University
Benha University, a leading institution in Egypt, is dedicated to advancing medical research and innovation through rigorous clinical trials. With a strong emphasis on multidisciplinary collaboration, the university aims to enhance healthcare outcomes by exploring novel therapeutic approaches and interventions. Its state-of-the-art facilities and commitment to ethical research practices ensure that all trials are conducted with the highest standards of integrity and scientific rigor. Benha University actively contributes to the global medical community by fostering partnerships and disseminating findings that can improve patient care and inform public health policies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Benha, , Egypt
Patients applied
Trial Officials
Ahmed Mostafa Abd El-hamed, Professor
Study Director
Benha University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported