CDSS of Traditional Chinese Medicine Intervention for Dry Eye Syndrome

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

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.

Study Overview

• Status: Unknown
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Behavioral: Clinical Decision Support System; Other: Routine intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xue hong; Phone Number: +8610-82265571; Email: hongxue@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Yuan Li Tao, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDSS group; Subjects' treatment regimens were influenced by the CDSS, which was the recommended system for Tradictional Chinese Medicine treatment of dry eye.	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.
Active Comparator: non-CDSS group; The treatment of the subjects was routine and not affected by the CDSS for Tradictional Chinese Medicine.	Other: Routine intervention; The routine intervention without CDSS is also the clinically common intervention at present.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Liyuan Tao, PhD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 2020-4-40915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are considering whether to share the data obtained from the study with the whole group of researchers, but the data to be Shared must be de-labeled data for the purpose of subject protection.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No