Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
1 other identifier
interventional
20
1 country
2
Brief Summary
This project is designed as a prospective, randomized, open, controlled clinical trial. For the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 22, 2020
CompletedFirst Submitted
Initial submission to the registry
December 6, 2020
CompletedFirst Posted
Study publicly available on registry
December 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedNovember 23, 2022
September 1, 2020
1.5 years
December 6, 2020
November 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Score
Ask the patient to mark the corresponding position on the ruler that can represent the pain or discomfort during the onset
The treatment period for each enrolled subject is one month
Secondary Outcomes (6)
OSDI
The treatment period for each enrolled subject is one month
TBUT
The treatment period for each enrolled subject is one month
SIt
The treatment period for each enrolled subject is one month
CFS score
The treatment period for each enrolled subject is one month
Density and curvature of corneal subbasal nerve
The treatment period for each enrolled subject is one month
- +1 more secondary outcomes
Study Arms (2)
Artificial tears
EXPERIMENTALArtificial tears
Acupuncture
ACTIVE COMPARATORAcupuncture
Interventions
eye drops, three times a day
Eligibility Criteria
You may qualify if:
- According to the DEWS diagnostic criteria, the OSDI score ≥ 13, with positive signs of dry eye (SIt ≤ 10mm/5min or TBUT ≤ 10s) or CFS positive;
- VAS\>0;
- Signed informed consent.
You may not qualify if:
- Patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days;
- Eyeball infections, allergies, deformities, abnormal movements
- Any history of eye surgery
- Have had eye trauma or fundus laser treatment within 3 months
- Used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days
- Suffer from systemic diseases that affect tear production, including Sjogren's syndrome, diabetes, mental illness, malignant tumors, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Peking University Third Hospital
Beijing, 100191, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2020
First Posted
December 16, 2020
Study Start
September 22, 2020
Primary Completion
March 30, 2022
Study Completion
June 30, 2022
Last Updated
November 23, 2022
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share