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

2026年8月15日 更新者：Peiyao Jin、Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200080
        • Shanghai General Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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
设备：Hydrogel-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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Absolute Error of CLS-Predicted Intraocular Pressure Compared With Goldmann Applanation Tonometry
大体时间：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.
Day 1, at the third validation measurement

次要结果测量

结果测量
措施说明
大体时间
Agreement Between CLS-Predicted Intraocular Pressure and Non-Contact Tonometry
大体时间：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.
Day 1, at the third validation measurement
Increased incidence of corneal fluorescent staining grade
大体时间：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)
Baseline and at the post-study ocular examination on Day 1
Conjunctival congestion score
大体时间：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.
Baseline and at the post-study ocular examination on Day 1
Change From Baseline in Tear Break-Up Time After CLS Wear
大体时间：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.
Baseline and at the post-study ocular examination on Day 1
Change From Baseline in Best-Corrected Visual Acuity After CLS Wear
大体时间：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.
Baseline and at the post-study ocular examination on Day 1
CLDEQ-8-Based Immediate Ocular Tolerability Questionnaire
大体时间：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.
Immediately after completion of CLS wear on Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月30日

初级完成 (估计的)

2026年11月30日

研究完成 (估计的)

2027年2月18日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月15日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年8月15日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 20260424074539870

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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