CDSS of Traditional Chinese Medicine Intervention for Dry Eye Syndrome

NCT ID: NCT04806256

Last Updated: 2021-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-11

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CDSS group

Subjects' treatment regimens were influenced by the CDSS, which was the recommended system for Tradictional Chinese Medicine treatment of dry eye.

Group Type EXPERIMENTAL

Clinical Decision Support System

Intervention Type BEHAVIORAL

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.

non-CDSS group

The treatment of the subjects was routine and not affected by the CDSS for Tradictional Chinese Medicine.

Group Type ACTIVE_COMPARATOR

Routine intervention

Intervention Type OTHER

The routine intervention without CDSS is also the clinically common intervention at present.

Interventions

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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.

Intervention Type BEHAVIORAL

Routine intervention

The routine intervention without CDSS is also the clinically common intervention at present.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liyuan Tao, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liyuan Tao, PhD

Role: CONTACT

+8610-82265571

xue hong

Role: CONTACT

+8610-82265571

Facility Contacts

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Yuan Li Tao, Ph.D

Role: primary

Other Identifiers

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2020-4-40915

Identifier Type: -

Identifier Source: org_study_id

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