Intraocular Pressure
Conditions
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.
Interventions
DEVICEHydrogel-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.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between CLS-Predicted Intraocular Pressure and Non-Contact Tonometry | Day 1, at the third validation measurement | 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 | Baseline and at the post-study ocular examination on Day 1 | 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 | Baseline and at the post-study ocular examination on Day 1 | 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 | Baseline and at the post-study ocular examination on Day 1 | 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. |
| Change From Baseline in Best-Corrected Visual Acuity After CLS Wear | Baseline and at the post-study ocular examination on Day 1 | Best-corrected visual acuity (BCVA) will be assessed before and after CLS wear. Change from baseline will be calculated by comparing the post-study BCVA with the baseline BCVA. |
| CLDEQ-8-Based Immediate Ocular Tolerability Questionnaire | Immediately after completion of CLS wear on Day 1 | Immediate ocular tolerability during wear of the investigational contact lens sensor (CLS) will be assessed using a study-specific questionnaire adapted from the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The questionnaire contains eight items assessing: frequency and intensity of ocular discomfort, frequency and intensity of ocular dryness, frequency and intensity of fluctuating or blurred vision, frequency of wanting to close the eye because of discomfort, and the desire to remove the CLS because of discomfort. Frequency items are scored from 0 to 4, intensity items from 0 to 5, and the item assessing the desire to remove the CLS from 1 to 6. Higher scores indicate worse ocular tolerability. |
Countries
China
Contacts
CONTACTPeiyao Jin
Outcome results
None listed