Clinical trial NCT04806256: CDSS of Traditional Chinese Medicine Intervention for Dry Eye Syndrome
Official title: Construction and Evaluation of CDSS Based on AI of Traditional Chinese Medicine Intervention for Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Ocular Surface Disease Index
timeFrame: Change from Before OSDI at 12 months after treatment
measure: Meibomain Gland Scale
timeFrame: Change from Before MGFS at 12 months after treatment
Secondary outcomes:
measure: Tear Meniscus Height
timeFrame: Change from Before TMH at 12 months after treatment
measure: Tear Break up time
timeFrame: Change from Before TBUT at 12 months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Liyuan Tao, PhD
role: PRINCIPAL_INVESTIGATOR
References: