Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor Tonometer

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• PIB repeatability in human eyes — Timeframe from enrollment to end of test will be a maximum of 60 minutes
  To evaluate IOP as measured by PIB in a side-by-side comparison of PIB and GAT in 30 human eyes (15 human subjects) with or without a glaucoma diagnosis. Note: This sample size is unlikely to provide enough ML training to test accuracy. Instead, this data will be tested on a pig eye ML model to assess repeatability. This data will also be used to inform our statistical analysis that will guide a subsequent accuracy study sample size.

Trial sites (1)