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

Safety, Tolerability, and Accuracy of a Novel Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor in Healthy Adults: A Single-Center, Single-Arm Exploratory Clinical Trial

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.

Inclusion Criteria:

• 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.
• Corneal curvature between 42 and 44 D, inclusive.

Exclusion Criteria:

• 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.