跳至主要内容
临床试验/NCT04806256
NCT04806256Unknown不适用

Construction and Evaluation of CDSS Based on AI of Traditional Chinese Medicine Intervention for Dry Eye Syndrome

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年7月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Ocular Surface Disease Index

研究概览

简要总结

This project is based on artificial intelligence (AI) algorithms to screen the effective methods of traditional Chinese medicine intervention for dry eye and its applicable conditions, and optimize the traditional Chinese medicine intervention plan for dry eye through the evaluation of evidence-based medicine and expert consensus, and construct the Clinical Decision support system of traditional Chinese medicine intervention for dry eye, secondly, a real-world prospective cohort study design is adopted, the CDSS system is used in the ophthalmology clinic, and its practical application effect on patients with dry eye is evaluated.

详细描述

Dry eye is a common disease that affects tears and ocular surface. It can cause ocular surface discomfort, visual impairment and even blindness, affect the quality of life of patients and cause social and psychological harm. Interventions related to traditional Chinese medicine can effectively alleviate the clinical symptoms and signs of patients with dry eye, and are an indispensable part of the treatment of dry eye. However, at present, patients with dry eye are mainly diagnosed at the western medicine ophthalmology clinic. Due to the lack of knowledge of Chinese medicine by western medicine ophthalmologists, they are unable to provide patients with good guidance on Chinese medicine intervention measures, which may cause patients to miss Chinese medicine-related treatments. This project provides doctors of Western medicine with a clinical decision support system (CDSS) of Chinese medicine interventions for dry eye syndrome, so as to improve doctors' guidance and decision-making of Chinese medicine for patients. This project is based on artificial intelligence (AI) algorithms to screen the effective methods of traditional Chinese medicine intervention for dry eye and its applicable conditions, and optimize the traditional Chinese medicine intervention plan for dry eye through the evaluation of evidence-based medicine and expert consensus, and construct the Clinical Decision support system of traditional Chinese medicine intervention for dry eye, secondly, a real-world prospective cohort study design is adopted, the CDSS system is used in the ophthalmology clinic, and its practical application effect on patients with dry eye is evaluated.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 to 80 year-old.
  • Meet the diagnostic criteria for dry eye, including ocular surface symptoms and signs.

排除标准

  • There are contradictions in diagnostic information, and the real condition of the disease is doubtful;
  • The absence of necessary observation indicators;
  • Lack of necessary prognostic information;
  • The informed consent is not approved.

结局指标

主要结局

Ocular Surface Disease Index

时间窗: Change from Before OSDI at 12 months after treatment

Ocular Surface Disease Index (OSDI) is a potential useful instrument for the assessment of vision.

Meibomain Gland Scale

时间窗: Change from Before MGFS at 12 months after treatment

Meibomian gland function score (MGFS) is used to evaluate the function of the meibomian glands and whether there is meibomian gland dysfunction.

次要结局

  • Tear Break up time(Change from Before TBUT at 12 months after treatment)
  • Tear Meniscus Height(Change from Before TMH at 12 months after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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