Effect of laser acupuncture on dry eye: A study protocol for a 2-center randomized controlled trial

BACKGROUND: Dry eye is a common ophthalmologic disorder that causes ocular discomfort and has become a worldwide health concern. Patients with dry eye often turn to complementary and alternative medicine (CAM) because of unsatisfactory conventional treatments. Acupuncture is one of the most popular interventions of CAM used, and laser acupuncture (LA) is a noninvasive technique. METHODS: This protocol is a 2-center randomized controlled trial investigating the effect of laser acupuncture on dry eye. Two hundred participants aged 20 to 65 years will be randomly assigned to the experimental group (LA plus conventional treatment) or the sham control group (LA without laser output plus conventional treatment) at 2 clinical research centers in South Taiwan. The subjects will undergo LA treatment thrice a week for 12 weeks. The subjects in the experimental group will sequentially receive 0.375 J of energy at each of the following acupoints: BL2, TE23, ST2, LI4, ST36, and GB37. The subjects in the control group will also receive a sham LA treatment, without any laser output. Outcome assessments will include evaluation of the ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer-I test finding, and the visual analog scale (VAS) score at 4 and 12 weeks before treatment. The OSDI, TFBUT, Schirmer-I test result, and VAS score of the participants will be analyzed and compared between the experimental and control groups using the paired t test and one-way analysis of variance. OBJECTIVES: The aim of this protocol is to investigate the efficacy of LA therapy in patients with dry eye. TRIAL REGISTRATION: ClinicalTrials.gov NCT03204903.