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

NCT07762053 | Not Yet Recruiting FDA Device

• 2 other identifiers: CL-0001R43EY037593-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Intraocular pressure measurement; Glaucoma; Tonometry, Ocular; ocular hypertension

Outcome Measures

Primary Outcomes (1)

• PIB repeatability in human eyes

  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.

  Timeframe from enrollment to end of test will be a maximum of 60 minutes

Secondary Outcomes (2)

• PIB safety in human eyes

  Timeframe from enrollment to the end of test will be a maximum of 60 minutes

• PIB comfort in human eyes

  The timeframe from enrollment to end of test will be no more than 60 minutes.

Other Outcomes (1)

• Influence of sequential PIB and GAT measurements on IOP

  Timeframe from enrollment to end of test will be a maximum of 60 minutes.

Study Arms (1)

A Prospective, Non-Randomized, Single-Center Clinical Investigation of PIB

EXPERIMENTAL

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.

Device: Photobionic IOP Tonometer (PIB)

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.

A Prospective, Non-Randomized, Single-Center Clinical Investigation of PIB

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a female or male;
• Subject is with or without a prior glaucoma diagnosis;
• Subject is 18 years or older;
• Subject is willing and able to sign an informed consent;
• Subjects considered to be vulnerable (i.e. individuals with impaired consent capacity and/or lack or loss of autonomy on the condition that written consent is provided by a legally authorized representative.

You may not qualify if:

• Subjects who are prisoners
• Subject refuses or is unable to sign the informed consent;
• Subjects with only one functional eye;
• Those with poor or eccentric fixation in one or both eyes;
• Those with corneal scarring or who have had corneal surgery including corneal laser surgery;
• Those with a history of incisional glaucoma or incisional retinal surgery;
• Microphthalmos;
• Buphthalmos;
• Contact lens use within the last three months;
• Symptoms of Dry Eye Syndrome and signs of dry eye on examination of cornea;
• Known history of difficulty in obtaining GAT IOP measurements;
• Lid squeezers or blepharospasm;
• Nystagmus;
• Keratoconus;
• Any corneal or conjunctival pathology or infection;

Sponsors & Collaborators

• EyeCBetter Corporation: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Acuity Eye Group

La Quinta, California, 92253-9508, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Joel Solano, MD

  EyeCBetter Corpoaration

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel M Solano, MD

CONTACT

602-828-1781; joels@eyecbetter.com

David W Anderson, BA, BS

CONTACT

612-839-6341; daveand439@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start date Jan 2027; End date Jan 2032
• Access Criteria: Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication by EyeCBetter Corp under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This data will be made available to researchers beginning immediately following completion of the study.

Locations

US (1)