The occurrence and progression of eye diseases like glaucoma are closely related to intraocular pressure fluctuations. Traditional single-point intraocular pressure measurement methods cannot reflect daily dynamic changes and are prone to missing hidden intraocular pressure peaks, limiting precise diagnosis and individualized treatment. This project aims to evaluate the wearing safety and measurement accuracy of a new low-modulus, high-strength hydrogel wearable dynamic intraocular pressure sensor. This product adopts the form of smart contact lenses, fully embedding a micro sensor into a hydrogel lens, combined with an external antenna mount and a portable recorder to continuously detect and wirelessly record even slight changes in corneal curvature, thereby obtaining real-time intraocular pressure fluctuation trend data. Based on this, the objective of this study is to evaluate the safety, measurement accuracy and tolerabilityof a wearable dynamic intraocular pressure sensor based on a novel hydrogel in healthy volunteers.
Voluntarily agrees to participate in the study and provides written informed consent.
Has previously worn contact lenses.
Has no ocular disease other than refractive error.
Central corneal thickness between 540 and 560 μm, inclusive.
Unable to tolerate the hydrogel-based wearable dynamic intraocular pressure sensor.
Pregnant or breastfeeding.
History of allergy to relevant medical materials or known hypersensitivity to materials used in the investigational device.
Single group
Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor
DeviceThe investigational device is a wearable hydrogel-based contact lens sensor designed to record electrical signals associated with changes in intraocular pressure. The CLS is worn on the study eye and allowed to stabilize for 10 minutes before signal acquisition. Sensor signals are obtained at three predefined measurement points and compared with Goldmann applanation tonometry measurements to assess measurement accuracy.
Absolute Error of CLS-Predicted Intraocular Pressure Compared With Goldmann Applanation Tonometry
The first two paired measurements of the contact lens sensor (CLS) signal and Goldmann applanation tonometry (GAT) intraocular pressure will be used to establish an individualized linear calibration equation for each participant. The third CLS signal will be converted to a predicted intraocular pressure using the individualized calibration equation. Absolute error is defined as the absolute difference between the CLS-predicted intraocular pressure and the corresponding GAT measurement, expressed in mmHg.
Agreement Between CLS-Predicted Intraocular Pressure and Non-Contact Tonometry
At the third validation assessment, intraocular pressure predicted from the contact lens sensor (CLS) using the individualized calibration equation will be compared with the corresponding non-contact tonometry (NCT) measurement.
Increased incidence of corneal fluorescent staining grade
Corneal fluorescence staining grading (National Eye Institute (NEI) standards) The cornea is divided into five regions (central, top, and above).Square, inferior, nasal side, temporal side), each area scores 0-3 points (0 = unstained, 1 = sparse dots, 2 = dense dots, 3 = fused or patchy)
Conjunctival congestion score
The Ora Calibra® scale was used to measure conjunctival redness in each eye. Each eye will be rated on a scale from 0 to 4, with 0 being best and 4 being the worst.
Change From Baseline in Tear Break-Up Time After CLS Wear
Tear break-up time (TBUT) will be measured before and after CLS wear. After blinking several times, the participant will keep the eye open while looking straight ahead, and the time until the first dry spot appears in the tear film will be recorded in seconds.
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