NCT03529370 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Robba C, Cardim D, Tajsic T, Pietersen J, Bulman M, Rasulo F, Bertuetti R, Donnelly J, Xiuyun L, Czosnyka Z, Cabeleira M, Smielewski P, Matta B, Bertuccio A, Czosnyka M
Non-invasive Intracranial Pressure Assessment in Brain Injured Patients Using Ultrasound-Based Methods. Acta Neurochir Suppl. 2018;126:69-73. doi: 10.1007/978-3-319-65798-1_15.
Wang LJ, Chen LM, Chen Y, Bao LY, Zheng NN, Wang YZ, Xing YQ
Ultrasonography Assessments of Optic Nerve Sheath Diameter as a Noninvasive and Dynamic Method of Detecting Changes in Intracranial Pressure. JAMA Ophthalmol. 2018 Mar 1;136(3):250-256. doi: 10.1001/jamaophthalmol.2017.6560.

Sonography of the Optic Nerve Sheath Diameter for Detection of Elevated Intracranial Pressure Compared to Computed Tomography

Clinical trial NCT03529370 - References