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临床试验/NCT07614347
NCT07614347尚未招募不适用

Development and Evaluation of an Intelligent Diagnosis System for Dry Eye Disease Based on Confocal Microscopy

Capital Medical University0 个研究点目标入组 75 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75

研究概览

简要总结

Dry eye disease is a major ophthalmic health issue that severely affects the visual function and quality of life of the national population. Its core pathological mechanism involves a vicious cycle of ocular surface inflammation and neural abnormalities; however, clinical practice still lacks an objective and quantitative gold standard for diagnosis. Although in vivo confocal microscopy (IVCM) enables cellular-level, in vivo observation of the ocular surface, image analysis remains heavily dependent on manual interpretation, highlighting an urgent need for an intelligent quantitative framework.This project aims to construct a high-quality, standardized ocular surface imaging database and develop a high-precision deep learning algorithm to achieve accurate segmentation and quantification of corneal nerves (including both whorl-like and linear patterns) and inflammatory cells, and to validate their associations with clinical indicators of dry eye disease. The ultimate goal is to develop and evaluate an IVCM-based multimodal intelligent diagnostic system for dry eye, transforming IVCM from an observational tool into an intelligent decision-support system, with real-world performance validated through an independent prospective cohort.This project is expected to establish a multimodal AI diagnostic model for dry eye, create a standardized computational framework for imaging biomarkers, and enable a paradigm shift from qualitative description to quantitative diagnosis. The findings will provide reliable decision-making support for precision subtyping and personalized treatment of dry eye disease, advancing ophthalmic practice toward a data-driven, intelligent paradigm.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Normal group:
  • Healthy adults aged 18 to 60;
  • OSDI score of ocular surface disease Index <13 points;
  • Good tear film stability (tear film break-up time TBUT≥10 seconds) and negative corneal fluorescein staining;
  • Dry eye Group:
  • Healthy adults aged 18 to 60;
  • Tear film break-up time ≤5 seconds or SchirmerⅠ≤5mm/5min without surface anesthesia, with one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or vision fluctuation in the eyes;
  • 5 <Tear film break-up time ≤10 seconds or 5mm/5 min/less under no surface anesthesia; When SchirmerⅠ is ≤10 mm/5min, there is one of the subjective symptoms in the eyes, such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and vision fluctuation. At the same time, the fluorescein staining of the cornea and conjunctiva is positive.

排除标准

  • Combined with systemic diseases or neurological diseases that may affect corneal nerve function;
  • Having used any local anti-inflammatory drugs for the eyes within 2 weeks before enrollment or having a history of wearing contact lenses within 3 months;
  • Other eye diseases besides dry eye and history of eye surgery;

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan Chen

PhD

Capital Medical University

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