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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peiyao Jin
- Phone Number: +8613564534911
- Email: peiyaojin@hotmail.com
Study Locations
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200080
- Shanghai General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor
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 |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Absolute Error of CLS-Predicted Intraocular Pressure Compared With Goldmann Applanation Tonometry
Time Frame: Day 1, at the third validation measurement
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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.
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Day 1, at the third validation measurement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Agreement Between CLS-Predicted Intraocular Pressure and Non-Contact Tonometry
Time Frame: Day 1, at the third validation measurement
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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.
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Day 1, at the third validation measurement
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Increased incidence of corneal fluorescent staining grade
Time Frame: Baseline and at the post-study ocular examination on Day 1
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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)
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Baseline and at the post-study ocular examination on Day 1
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Conjunctival congestion score
Time Frame: Baseline and at the post-study ocular examination on Day 1
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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.
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Baseline and at the post-study ocular examination on Day 1
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Change From Baseline in Tear Break-Up Time After CLS Wear
Time Frame: Baseline and at the post-study ocular examination on Day 1
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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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Baseline and at the post-study ocular examination on Day 1
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Change From Baseline in Best-Corrected Visual Acuity After CLS Wear
Time Frame: Baseline and at the post-study ocular examination on Day 1
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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.
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Baseline and at the post-study ocular examination on Day 1
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CLDEQ-8-Based Immediate Ocular Tolerability Questionnaire
Time Frame: Immediately after completion of CLS wear on Day 1
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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. |
Immediately after completion of CLS wear on Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20260424074539870
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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