CDSS of Traditional Chinese Medicine Intervention for Dry Eye Syndrome

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806256
• Other study ID #: 2020-4-40915
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2020
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: Peking University Third Hospital
• Contact: Liyuan Tao, PhD
• Phone: +8610-82265571
• Email: tendytly[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Behavioral:
• Clinical Decision Support System
This project is based on the artificial intelligence (AI) algorithm 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 traditional Chinese medicine intervention Clinical Decision Support Systems (CDSS) for dry eye. At the same time, the CDSS is provided to clinicians for their selection.

Other:
• Routine intervention
The routine intervention without CDSS is also the clinically common intervention at present.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index	Ocular Surface Disease Index (OSDI) is a potential useful instrument for the assessment of vision.	Change from Before OSDI at 12 months after treatment
Primary	Meibomain Gland Scale	Meibomian gland function score (MGFS) is used to evaluate the function of the meibomian glands and whether there is meibomian gland dysfunction.	Change from Before MGFS at 12 months after treatment
Secondary	Tear Meniscus Height	Tear Meniscus Height (TMH) refers to the level of tear fluid at the junction of the light band on the surface of the cornea and conjunctiva and the light band on the lower eyelid margin.	Change from Before TMH at 12 months after treatment
Secondary	Tear Break up time	Tear Break up time (TBUT) is usually used to diagnose dry eye syndrome. Diluted fluorescein sodium liquid is instilled into the conjunctival fornix of the lower eyelid, and the patient is instructed to blink and hold it, and start timing. The time when the first rupture spot appears is the tear film rupture time.	Change from Before TBUT at 12 months after treatment