Intraocular PressureNCT07770178
Safety, Tolerability, and Accuracy of a Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor in Healthy Adults
A study testing Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor in people with Intraocular Pressure, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 18 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Intraocular Pressure
- Being tested
- Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel-Based Wearable Dynamic Intraocular Pressure SensorDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, at the third validation measurement
Secondary outcomes (6)
Agreement Between CLS-Predicted Intraocular Pressure and Non-Contact Tonometry
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.
Measured: Day 1, at the third validation measurement
Increased incidence of corneal fluorescent staining grade
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)
Measured: Baseline and at the post-study ocular examination on Day 1
Conjunctival congestion score
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.
Measured: Baseline and at the post-study ocular examination on Day 1
Change From Baseline in Tear Break-Up Time After CLS Wear
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.
Measured: Baseline and at the post-study ocular examination on Day 1
Change From Baseline in Best-Corrected Visual Acuity After CLS Wear
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.
Measured: Baseline and at the post-study ocular examination on Day 1
CLDEQ-8-Based Immediate Ocular Tolerability Questionnaire
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.
Measured: Immediately after completion of CLS wear on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion18 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiyao Jin, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770178
- Sponsor's protocol ID
- 20260424074539870
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07770178
- Acronym / sponsor ID
- 20260424074539870
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 18 Feb 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor | Experimental | Device: Hydrogel-Based Wearable Dynamic Intraocular Pressure SensorParticipants 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogel-Based Wearable Dynamic Intraocular Pressure SensorThe 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. | Device | Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor |
Primary outcome
Absolute Error of CLS-Predicted Intraocular Pressure Compared With Goldmann Applanation Tonometry
Time frame: 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.
6 secondary outcomes
Agreement Between CLS-Predicted Intraocular Pressure and Non-Contact Tonometry
Time frame: Day 1, at the third validation measurement
Increased incidence of corneal fluorescent staining grade
Time frame: Baseline and at the post-study ocular examination on Day 1
Conjunctival congestion score
Time frame: Baseline and at the post-study ocular examination on Day 1
Change From Baseline in Tear Break-Up Time After CLS Wear
Time frame: Baseline and at the post-study ocular examination on Day 1
Change From Baseline in Best-Corrected Visual Acuity After CLS Wear
Time frame: Baseline and at the post-study ocular examination on Day 1
CLDEQ-8-Based Immediate Ocular Tolerability Questionnaire
Time frame: Immediately after completion of CLS wear on Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor in people with Intraocular Pressure, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peiyao Jin (+8613564534911, peiyaojin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Error of CLS-Predicted Intraocular Pressure Compared With Goldmann Applanation Tonometry (time frame: Day 1, at the third validation measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.