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

Conditions

• Elevated Intraocular Pressure (IOP)

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Accepted

Interventions

• Photobionic IOP Tonometer (PIB) — DEVICE
  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 Details

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.

Key Dates

First listed

Aug 13, 2026

Start date

Aug 31, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: A Prospective, Non-Randomized, Single-Center Clinical Investigation of PIB
  This study will employ a prospective, non-randomized study design to address the safety and comfort of PIB as compared to GAT. As PIB does not require eye contact and anesthetic drops, the PIB test will be performed first to prevent any confounding influences of eye contact and anesthetic drops required by the GAT test. A PIB test following the GAT test will be performed to verify that the act of repeated measurements does not significantly influence IOP (exploratory aim). IOP data obtained from this testing will be used to assess repeatability of measurements in human subjects and to inform the size of a subsequent human trial aiming to refine the PIB IOP model. The study will be conducted at Retina Institute of California dba Acuity Eye Group and is expected to enroll approximately 15 participants over a period of 1 month.

Primary Outcome Measure

PIB repeatability in human eyes [ Time Frame: Timeframe from enrollment to end of test will be a maximum of 60 minutes ]

Central Contacts

• Joel M Solano, MD
  602-828-1781
  [email protected]
• David W Anderson, BA, BS
  612-839-6341
  [email protected]

Locations (1)

Find similar trials in La Quinta, CA