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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 11, 2020
CompletedFirst Submitted
Initial submission to the registry
September 6, 2020
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 19, 2021
March 1, 2021
1.6 years
September 6, 2020
March 17, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Tear Meniscus Height
Change from Before TMH at 12 months after treatment
Tear Break up time
Change from Before TBUT at 12 months after treatment
Study Arms (2)
CDSS group
EXPERIMENTALSubjects' treatment regimens were influenced by the CDSS, which was the recommended system for Tradictional Chinese Medicine treatment of dry eye.
non-CDSS group
ACTIVE COMPARATORThe treatment of the subjects was routine and not affected by the CDSS for Tradictional Chinese Medicine.
Interventions
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.
The routine intervention without CDSS is also the clinically common intervention at present.
Eligibility Criteria
You may qualify if:
- Ages 18 to 80 year-old.
- Meet the diagnostic criteria for dry eye, including ocular surface symptoms and signs.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liyuan Tao, PhD
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2020
First Posted
March 19, 2021
Study Start
July 11, 2020
Primary Completion
March 1, 2022
Study Completion
December 1, 2022
Last Updated
March 19, 2021
Record last verified: 2021-03