A Prospective, Non-Randomized, Single-Center Clinical Investigation of the Safety and Performance of Eye C Better's Photobionic IOP Biomonitor Tonometer (PIB)
EyeCBetter Corporation
Summary
The device being studied in this research is the investigational PIB, a tool designed to measure eye pressure without touching the eye. The device uses a very low-power, eye-safe infrared light and a gentle sound signal to detect tiny movements on the white part of the eye. A camera records these movements, and a computer analyzes the information to estimate eye pressure. The test takes only a few seconds and does not require eye drops or contact with the eye. The device rests near your face using a chin and forehead support, like equipment used in an eye doctor's office. The PIB aims to provide the following possible benefits over the devices doctors may be using now including the GAT: * No touching of the eye to lower the risk of infection and discomfort * Improved accuracy and precision * Faster eye pressure measurements * Measurements that may be done by a patient at home without the need for a doctor * A low-cost eye pressure measurement device that may be used in areas where there are fewer doctors The PIB device is investigational, which means that it is not approved by the Food and Drug Administration (FDA). The GAT device has been approved by the FDA.
Description
Background of the problem: epidemiology, prevalence/incidence Glaucoma is the leading source of irreversible blindness and the second leading cause of the condition, resulting in a global burden on a massive scale, especially in developing countries. The disease is characterized by a series of progressive optic neuropathies, defined by the deterioration of retinal ganglion cells and retinal nerve fiber layers, causing abnormalities in the optical nerve head. High intraocular pressure (IOP) leads to optic nerve degeneration and the death of the retinal ganglion cells. Vision loss from this dis…