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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04668131

Collaborator

(none)

200

Enrollment

Arms

5.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Sodium hyaluronate eye drops Other: acupuncture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artificial tears	Drug: Sodium hyaluronate eye drops eye drops, three times a day
Active Comparator: Acupuncture	Other: acupuncture three times a week

Arm

Intervention/Treatment

Experimental: Artificial tears

Drug: Sodium hyaluronate eye drops

eye drops, three times a day

Active Comparator: Acupuncture

Other: acupuncture

three times a week

Outcome Measures

Primary Outcome Measures

Visual Analogue Score [The treatment period for each enrolled subject is one month]
Ask the patient to mark the corresponding position on the ruler that can represent the pain or discomfort during the onset

Secondary Outcome Measures

OSDI [The treatment period for each enrolled subject is one month]
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.
TBUT [The treatment period for each enrolled subject is one month]
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
SIt [The treatment period for each enrolled subject is one month]
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
CFS score [The treatment period for each enrolled subject is one month]
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.
Density and curvature of corneal subbasal nerve [The treatment period for each enrolled subject is one month]
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
Tear pain factor content [The treatment period for each enrolled subject is one month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.