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

NCT ID: NCT04668131

Last Updated: 2022-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Artificial tears

Artificial tears

Group Type EXPERIMENTAL

Sodium hyaluronate eye drops

Intervention Type DRUG

eye drops, three times a day

Acupuncture

Acupuncture

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type OTHER

three times a week

Interventions

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Sodium hyaluronate eye drops

eye drops, three times a day

Intervention Type DRUG

acupuncture

three times a week

Intervention Type OTHER

Other Intervention Names

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artificial tears

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University Third Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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20200922

Identifier Type: -

Identifier Source: org_study_id

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