Laser Acupuncture for Dry Eye

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03204903
• Other study ID #: CMRPG8F0551
• Secondary ID: 201600333A3
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2018
• Source: Chang Gung Memorial Hospital
• Contact: Wen-Long Hu, MD, MS
• Phone: +886-7-7317123
• Email: oolonghu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Procedure:
• Laser acupuncture
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.
• Sham laser acupuncture
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Shin MS, Kim JI, Lee MS, Kim KH, Choi JY, Kang KW, Jung SY, Kim AR, Kim TH. Acupuncture for treating dry eye: a randomized placebo-controlled trial. Acta Ophthalmol. 2010 Dec;88(8):e328-33. doi: 10.1111/j.1755-3768.2010.02027.x. Epub 2010 Nov 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Schirmer test	A Schirmer's test is used to assess how quickly the eyes produce tears.	12 weeks
Secondary	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
Secondary	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