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

2026年5月26日 更新者:Dan Chen、Capital Medical University
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.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

75

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

不适用

取样方法

非概率样本

研究人群

This study intends to include patients with dry eye and healthy controls as the research subjects.

描述

Inclusion Criteria:

Normal group:

  1. Healthy adults aged 18 to 60;
  2. OSDI score of ocular surface disease Index <13 points;
  3. Good tear film stability (tear film break-up time TBUT≥10 seconds) and negative corneal fluorescein staining;

Dry eye Group:

  1. Healthy adults aged 18 to 60;
  2. 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;
  3. 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.

Exclusion Criteria:

  1. Combined with systemic diseases or neurological diseases that may affect corneal nerve function;
  2. 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;
  3. Other eye diseases besides dry eye and history of eye surgery;

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

队列和干预

团体/队列
控制组
dry eye group

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
in vivo confocal microscopy examination
大体时间:Baseline
Images of the central corneal area and the inferior thread area of the patients were collected using in vivo confocal microscopy. During the examination, the patient's lower jaw is placed on the bracket, the forehead is tightly against the frontal support, and the patient is fixated on the target. A corneal contact probe is used. After applying Carbomer gel, it touches the corneal surface and scans layer by layer to obtain images of each layer of the cornea. The clear images of the linear nerves in the central area of the cornea and the vortex-like nerves in the lower vortex-like area were mainly collected for the subsequent intelligent analysis system to extract the morphological parameters of the corneal nerves and the parameters of inflammatory cells.
Baseline

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。

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6月1日

初级完成 (估计的)

2028年10月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • TREC2026-KY070

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