Safety, Tolerability, and Accuracy of a Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor in Healthy Adults

Condition(s) studied

Investigational drug(s) / intervention(s)

Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor: The 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Absolute Error of CLS-Predicted Intraocular Pressure Compared With Goldmann Applanation Tonometry — Day 1, at the third validation measurement
  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.

Trial sites (1)

More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China

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