Laser Acupuncture for Dry Eye

Not Applicable

• Conditions: Dry Eye
• Interventions: Procedure: Sham laser acupuncture; Procedure: Laser acupuncture

• Registration Number: NCT03204903
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated.

Detailed Description

Objective: Dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. The investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye.

Methods: 200 subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-05-21
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 20 < age < 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent.
• Tear film break-up time < 10 s
• Schirmer's strips with anesthesia < 5mm/ 5min

Exclusion Criteria

• presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens
• pregnancy, diabetes mellitus, vitamin A deficiency, sequelae of Bell's palsy, hemodialysis
• critical illness such as Stevens-Johnson syndrome, etc
• has taken or needs active treatment (including Chinese medicine)
• presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin
• does not meet the physician's assessment for recruitment
• lack of informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham laser acupuncture	Sham laser acupuncture	The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using sham laser acupuncture (without laser output) during 3 sessions per week for 12 weeks.
Laser acupuncture	Laser acupuncture	The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using laser acupuncture during 3 sessions per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index	12 weeks	The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision.

Secondary Outcome Measures

Name	Time	Method
Schirmer test	12 weeks	A Schirmer's test is used to assess how quickly the eyes produce tears.
Visual analogue scale of eye discomfort	12 weeks	A 10-cm visual analog scale (0-10 points, least to greatest discomfort intensity, VAS) was used to measure the intensity of eye discomfort.
Tear film break-up time	12 weeks	Tear film break-up time (TFBUT) measures the time required for tears to naturally evaporate and diffuse after blinking.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan