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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04668131
• Other study ID #: 20200922
• Status: Completed
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Neuralgia

Intervention

Drug:
• Sodium hyaluronate eye drops
eye drops, three times a day

Other:
• acupuncture
three times a week

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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