Laser Acupuncture for Dry Eye

Chang Gung Medical Foundation

Status: Unknown

Conditions: Dry Eye

Treatments: Procedure: Laser acupuncture; Procedure: Sham laser acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03204903

201600333A3 (Other Identifier)

CMRPG8F0551

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

Laser acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Laser acupuncture

Sham laser acupuncture

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham laser acupuncture