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

NCT07762053 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-13

No results posted yet for this 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.

Conditions

  • Elevated Intraocular Pressure (IOP)

Interventions

DEVICE

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.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • EyeCBetter Corporation

    lead INDUSTRY

Principal Investigators

  • Joel Solano, MD · EyeCBetter Corpoaration

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762053 on ClinicalTrials.gov