{"title":"Biosensor-embedded wearables for dry eye monitoring and management.","authors":"Bharat Gurnani, Kirandeep Kaur","doi":"10.1080/17434440.2025.2555485","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Dry eye disease (DED) affects over 300 million people worldwide and continues to pose diagnostic challenges due to fluctuating symptoms and reliance on static, clinic-based tests. Conventional methods such as Schirmer's test and tear osmolarity provide only episodic insights, failing to capture the dynamic behavior of the tear film. Recently, biosensor-embedded wearable devices, including smart contact lenses, eyelid-mounted patches, and sensor-equipped spectacles, have emerged, enabling real-time and continuous tracking of tear metrics and blink patterns. These technologies promise precision diagnostics and patient-specific therapeutic strategies.</p><p><strong>Areas covered: </strong>This review summarizes recent advances in ocular biosensor wearables for DED. Key innovations include smart lenses with osmolarity and biomarker sensors, microfluidic channels for tear collection, and eyelid-mounted iontronic sensors for blink monitoring. Regulatory pathways such as FDA 510(k), ISO 10,993 safety standards, and HL7 FHIR for data integration are discussed. Early clinical studies support feasibility, though power supply, device miniaturization, and patient adherence remain obstacles. Ethical, economic, and privacy considerations are also highlighted.</p><p><strong>Expert opinion: </strong>Biosensor-based wearables are redefining DED care, offering precision diagnostics, early intervention, and long-term monitoring. Their success depends on clinical validation, affordability, patient comfort, and seamless integration with telehealth. Interdisciplinary collaboration will be crucial to transition these innovations into routine clinical practice.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1073-1079"},"PeriodicalIF":2.7000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert review of medical devices","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/17434440.2025.2555485","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/1 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Dry eye disease (DED) affects over 300 million people worldwide and continues to pose diagnostic challenges due to fluctuating symptoms and reliance on static, clinic-based tests. Conventional methods such as Schirmer's test and tear osmolarity provide only episodic insights, failing to capture the dynamic behavior of the tear film. Recently, biosensor-embedded wearable devices, including smart contact lenses, eyelid-mounted patches, and sensor-equipped spectacles, have emerged, enabling real-time and continuous tracking of tear metrics and blink patterns. These technologies promise precision diagnostics and patient-specific therapeutic strategies.
Areas covered: This review summarizes recent advances in ocular biosensor wearables for DED. Key innovations include smart lenses with osmolarity and biomarker sensors, microfluidic channels for tear collection, and eyelid-mounted iontronic sensors for blink monitoring. Regulatory pathways such as FDA 510(k), ISO 10,993 safety standards, and HL7 FHIR for data integration are discussed. Early clinical studies support feasibility, though power supply, device miniaturization, and patient adherence remain obstacles. Ethical, economic, and privacy considerations are also highlighted.
Expert opinion: Biosensor-based wearables are redefining DED care, offering precision diagnostics, early intervention, and long-term monitoring. Their success depends on clinical validation, affordability, patient comfort, and seamless integration with telehealth. Interdisciplinary collaboration will be crucial to transition these innovations into routine clinical practice.
干眼病(DED)影响着全世界超过3亿人,由于症状的波动和对静态的、基于临床的测试的依赖,干眼病继续构成诊断挑战。传统的方法,如Schirmer测试和泪液渗透压只能提供偶发性的见解,无法捕捉泪液膜的动态行为。最近,嵌入生物传感器的可穿戴设备,包括智能隐形眼镜、安装在眼睑上的贴片和配备传感器的眼镜,已经出现,可以实时、连续地跟踪眼泪指标和眨眼模式。这些技术有望实现精确诊断和针对患者的治疗策略。涵盖领域:本文综述了用于DED的眼生物传感器可穿戴设备的最新进展。关键的创新包括具有渗透压和生物标志物传感器的智能透镜,用于泪液收集的微流体通道,以及用于眨眼监测的安装在眼睑上的离子电子传感器。监管途径,如FDA 510(k), ISO 10993安全标准和HL7 FHIR数据集成进行了讨论。早期临床研究支持可行性,但电力供应、设备小型化和患者依从性仍然是障碍。道德、经济和隐私方面的考虑也被强调。专家意见:基于生物传感器的可穿戴设备正在重新定义DED护理,提供精确诊断、早期干预和长期监测。它们的成功取决于临床验证、可负担性、患者舒适度以及与远程医疗的无缝集成。跨学科合作对于将这些创新转化为常规临床实践至关重要。