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Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor Tonometer
Sponsor: 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.
Official title: A Prospective, Non-Randomized, Single-Center Clinical Investigation of the Safety and Performance of Eye C Better's Photobionic IOP Biomonitor Tonometer (PIB)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-08-31
Completion Date
2026-09
Last Updated
2026-09-10
Healthy Volunteers
Yes
Conditions
Interventions
Photobionic IOP Tonometer (PIB)
This study aims to evaluate the repeatability of IOP as measured in human eyes using Eye C Better Corp's Photonic IOP Biomonitor (PIB) Tonometer. PIB is a novel methodology allowing high-precision, non-contact, non-air puff, reproducible and semi-continuous IOP monitoring without clinician interpretation. PIB is based on observations in fish and porcine eyes, that sound waves induce scleral oscillations in an IOP dependent fashion. PIB measures these nanometric oscillations by monitoring speckle patterns generated with an eye-safe infrared laser reflected by the sclera. A high-speed camera records the speckle patterns and physical modelling combined with machine learning (ML) algorithms process this data to infer IOP. This technology will be configurable as a physician office-based platform and as a home-based device allowing the patient to self-measure IOP's frequently outside of the clinical setting for earlier detection and treatment of increased IOP.
Locations (1)
Acuity Eye Group
La Quinta, California, United States