Third Eye Diagnostics, Inc. is developing the Cerepress™, a first-of-its-kind non-invasive intracranial pressure monitor that gathers information from the patient's eye. The technology is based on one issued patent, one pending patent, and two applications in progress on methods and apparatus that correlate ICP with measurements taken from the blood vessels within the eye. The Cerepress™ measures blood pressure in the eye’s central retinal vein (CRV) which highly correlates to intracranial pressure.
To obtain CRV pressure, 3ED has developed a novel apparatus that simultaneously records images of the CRV and measures intraocular pressure (IOP) while pressure in the eye is increased. A medical technician aligns the system by easily centering the field of view to patient’s pupil eye. The system then contacts the patient’s cornea and simultaneously collects images of the cornea and the retinal fundus. The contact force increases the IOP and momentarily compresses the CRV. At the instant of complete CRV compression, the Cerepress™ records the eye pressure, which is equivalent to CRV pressure. CRV pressure is a known to be a good correlate to ICP.
The output of the device is a single point reading of intracranial pressure in units of mmHg, which can be performed serially as often as necessary.
Invasive ICP monitoring is a common tool for physicians treating patients with acute increases in ICP caused by severe head injury, intracranial hemorrhage, or stroke. The current standard of care to measure ICP involves surgically inserting a sensor into the cranium through an access hole that is drilled through the skull. This surgical procedure is expensive and exposes the patient to risks such as infection, malfunction and hemorrhaging. Because of these risks, ICP is only measured in patients who are critically ill.
According to the Centers for Disease Control, there are approximately 1.45 million new cases of traumatic brain injuries (TBIs) in the U.S. civilian population each year (and 10 million world-wide according to the World Health Organization). An additional 1.1 million U.S. patients per year suffer from conditions that lead to elevated ICP, placing them at risk for brain damage and death. The U.S. military reports that approximately 188,000 troops have suffered a TBI since 2000.
The rapid detection of elevated ICP in brain injuries is critical for physicians and first responders to develop the best therapy to reduce the chance of death and disability. CerePress™ addresses this need by providing medical personnel with the ability to rapidly assess and diagnose potentially life-threatening conditions in patients critically ill and who might not otherwise be candidates for invasive ICP monitoring.
In addition to head injury, ICP monitoring may have clinical utility for the detection and monitoring of glaucoma. It is estimated that there are 4 million cases of glaucoma in the U.S. and 65 million worldwide. Intraocular pressure (IOP) is the most common metric used for detecting and following glaucoma progression. However, a growing number of researchers have pro-posed that it is not IOP alone, but the pressure gradient across the optic nerve head that is the important measurement. However, to date this pressure gradient (specifically, the difference between IOP and ICP) has not been obtainable clinically. A device that can measure both IOP and ICP such as the CerePress™ could be greatly beneficial to the early detection of glaucoma.
- Diagnosis and/or monitoring of elevated intracranial pressure due to concussion or other traumatic brain injury.
- Diagnosis and/or monitoring of elevated intracranial pressure prior to the insertion of an invasive intracranial pressure monitor such as a ventriculostomy.
- Monitoring of patients at risk for intracranial hypertension secondary to non-head trauma (e.g., stroke, brain surgery, and hydrocephalus).