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

15 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200080
        • Shanghai General Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Absolute Error of CLS-Predicted Intraocular Pressure Compared With Goldmann Applanation Tonometry
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Agreement Between CLS-Predicted Intraocular Pressure and Non-Contact Tonometry
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 août 2026

Achèvement primaire (Estimé)

30 novembre 2026

Achèvement de l'étude (Estimé)

18 février 2027

Dates d'inscription aux études

Première soumission

12 août 2026

Première soumission répondant aux critères de contrôle qualité

15 août 2026

Première publication (Réel)

18 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 20260424074539870

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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