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

NCT07770178 | Not Yet Recruiting

• 1 other identifier: 20260424074539870
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1, at the third validation measurement

Secondary Outcomes (6)

• Agreement Between CLS-Predicted Intraocular Pressure and Non-Contact Tonometry

  Day 1, at the third validation measurement

• Increased incidence of corneal fluorescent staining grade

  Baseline and at the post-study ocular examination on Day 1

• Conjunctival congestion score

  Baseline and at the post-study ocular examination on Day 1

• Change From Baseline in Tear Break-Up Time After CLS Wear

  Baseline and at the post-study ocular examination on Day 1

• Change From Baseline in Best-Corrected Visual Acuity After CLS Wear

  Baseline and at the post-study ocular examination on Day 1

Study Arms (1)

Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor

EXPERIMENTAL

Participants will undergo a single-arm evaluation of a hydrogel-based wearable dynamic intraocular pressure sensor (CLS). After 2 hours of fasting from food and water, baseline ocular safety examinations will be performed. Intraocular pressure will first be measured using non-contact tonometry (NCT) and Goldmann applanation tonometry (GAT). Participants will then wear the CLS and undergo a 10-minute adaptation period before the first sensor signal is recorded. Participants will drink 1 L of water within 5 minutes. At 10-15 minutes after completion of water intake, a second sensor signal will be recorded, followed by CLS removal and repeat GAT and NCT measurements. After an interval of at least 45 minutes, NCT and GAT will be repeated, the CLS will be worn again for a 10-minute adaptation period, and a third sensor signal will be recorded. After completion of the measurement procedure, the CLS will be removed and ocular safety examinations will be repeated to evaluate changes associate

Device: Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor

Interventions

Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor DEVICE

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.

Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Central Study Contacts

Peiyao Jin

CONTACT

+8613564534911; peiyaojin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician of Ophthalmology

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 18, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)