[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652199":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":40,"collaborators":19,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":19,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":19,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":19,"overallStatus":63,"whyStopped":19,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nParticipants 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",[13],"Device: Hydrogel-Based Wearable Dynamic Intraocular Pressure Sensor",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","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.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Peiyao Jin","CONTACT","+8613564534911","peiyaojin@hotmail.com",[27],{"facility":28,"status":19,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":19},"Shanghai General Hospital","Shanghai","Shanghai Municipality","200080","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},{"type":41,"investigatorFullName":22,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Associate Chief Physician of Ophthalmology","100652199","safety-tolerability-and-accuracy-of-a-hydrogel-based-wearable-dynamic-intraocular-pressure-sensor-in-healthy-adults-100652199",false,"NCT07770178","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","Inclusion Criteria:\n\n* Voluntarily agrees to participate in the study and provides written informed consent.\n* Has previously worn contact lenses.\n* Has no ocular disease other than refractive error.\n* Central corneal thickness between 540 and 560 μm, inclusive.\n* Corneal curvature between 42 and 44 D, inclusive.\n\nExclusion Criteria:\n\n* Unable to tolerate the hydrogel-based wearable dynamic intraocular pressure sensor.\n* Pregnant or breastfeeding.\n* History of allergy to relevant medical materials or known hypersensitivity to materials used in the investigational device.",true,"ALL","20 Years","40 Years",{"count":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[59],"NA","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.",[62],"Intraocular Pressure","NOT_YET_RECRUITING","2026-08-15",{"date":66,"type":67},"2026-08-18","ACTUAL",{"date":69,"type":56},"2026-08-30",{"date":71,"type":56},"2027-02-18",{"name":5,"class":6},1]