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CDSS of Traditional Chinese Medicine Intervention for Dry Eye Syndrome

Primary Purpose

Dry Eye Syndromes

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Clinical Decision Support System
Routine intervention
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CDSS group

non-CDSS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 6, 2020
Last Updated
March 17, 2021
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04806256
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CDSS group
Arm Type
Experimental
Arm Description
Subjects' treatment regimens were influenced by the CDSS, which was the recommended system for Tradictional Chinese Medicine treatment of dry eye.
Arm Title
non-CDSS group
Arm Type
Active Comparator
Arm Description
The treatment of the subjects was routine and not affected by the CDSS for Tradictional Chinese Medicine.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Decision Support System
Intervention Description
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
Other
Intervention Name(s)
Routine intervention
Intervention Description
The routine intervention without CDSS is also the clinically common intervention at present.
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index
Description
Ocular Surface Disease Index (OSDI) is a potential useful instrument for the assessment of vision.
Time Frame
Change from Before OSDI at 12 months after treatment
Title
Meibomain Gland Scale
Description
Meibomian gland function score (MGFS) is used to evaluate the function of the meibomian glands and whether there is meibomian gland dysfunction.
Time Frame
Change from Before MGFS at 12 months after treatment
Secondary Outcome Measure Information:
Title
Tear Meniscus Height
Description
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.
Time Frame
Change from Before TMH at 12 months after treatment
Title
Tear Break up time
Description
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.
Time Frame
Change from Before TBUT at 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18 to 80 year-old. Meet the diagnostic criteria for dry eye, including ocular surface symptoms and signs. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liyuan Tao, PhD
Phone
+8610-82265571
Email
tendytly@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xue hong
Phone
+8610-82265571
Email
hongxue@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liyuan Tao, PhD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Li Tao, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

CDSS of Traditional Chinese Medicine Intervention for Dry Eye Syndrome

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