Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease

Study Overview
=================
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.

Official Title
-----------------
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Sodium hyaluronate eye drops
* Other: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial tears<br>Artificial tears | Drug: Sodium hyaluronate eye drops<br>* eye drops, three times a day<br>* Other names: artificial tears;|
| Active Comparator: Acupuncture<br>Acupuncture | Other: acupuncture<br>* three times a week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSDI | OSDI consists of 12 scoring items, divided into three parts: severity of symptoms, impact of symptoms on daily life, and impact of environment on symptoms. | The treatment period for each enrolled subject is one month | 
| TBUT | Drop 1 drop of 0.3% sodium fluorescein eye solution into the subject's conjunctival sac, dry it with a sterile cotton swab, and ask him to blink gently to make the fluorescein sodium evenly distributed. Observe the subject from the last time with a slit lamp cobalt blue light. The time from blinking to the first dark spot on the corneal surface, record three times and take the average | The treatment period for each enrolled subject is one month | 
| SIt | Fold one end of the special 5mm×35mm filter paper (Tianjin Jingming) for tears by 5mm, and gently place it on the middle and outer 1/3 of the subject's lower eyelid conjunctival sac, and the other end will droop naturally. Ask the subject to gently close their eyes for 5 minutes After measuring the length of the filter paper wetted by tears | The treatment period for each enrolled subject is one month | 
| CFS score | Divide the cornea into 5 quadrants (central + nose/temporal/upper/lower), each quadrant has a staining score of 0 to 3 points, and it is specified that no staining is 0 points, and 30 spots are stained as 1 point, and there is flaky staining and fusion 3 points for filament formation, 2 points between the two, the sum of 5 quadrants is the score of the entire cornea, and the CFS score of the entire cornea is 0-15 points. | The treatment period for each enrolled subject is one month | 
| Density and curvature of corneal subbasal nerve | Collect corneal subbasal nerve images, 2 images each in the upper, lower, arm, temporal and central areas. Use deep learning methods to analyze nerve density and curvature | The treatment period for each enrolled subject is one month | 
| Tear pain factor content | With the aid of a slit lamp, a capillary pipette was used to draw 5 μl tears/eye at the middle and outer edges of the lower eyelid 2/3 of the tear river, and placed in a low protein adhesion EP tube (containing 5 μl 1% BSA) and stored at -80°C. ELISA analyzes the protein levels of PGE2, substance P and NGF in tear fluid. | The treatment period for each enrolled subject is one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eye, pain, acupuncture