Laser Acupuncture for Dry Eye

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laser Acupuncture Therapy in Patients With Dry Eye: A Two-center Randomized Controlled Trial

Conditions
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Dry Eye

Intervention / Treatment
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* Procedure: Laser acupuncture
* Procedure: Sham laser acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser acupuncture<br>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. | Procedure: Laser acupuncture<br>* Subjects were treated 3 times per week for 12 weeks with the LaserPen (GaAlAs laser diode, 810 nm, 150 mW, pulsed waves), which delivered 0.375 J of energy (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.<br>|
| Sham Comparator: Sham laser acupuncture<br>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. | Procedure: Sham laser acupuncture<br>* Subjects were treated 3 times per week for 12 weeks with the LaserPen without laser output (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index | 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. | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Laser acupuncture, Traditional Chinese medicine