Evaluating Laser Acupuncture for Treating Dry Eye Symptoms in Patients With and Without Sjgrens Syndrome

What this Trial Is About

Researchers are evaluating the effects of adding laser acupuncture to standard care for treating dry eye symptoms in people with Sjgrens Syndrome-related dry eye SJS-DES and non-Sjgrens Syndrome-related dry eye Non-SJS-DES. This randomized, double-blind, placebo-controlled clinical trial aims to compare the benefits of active laser acupuncture against placebo and no treatment, involving a total of 140 patients divided evenly between the two dry eye populations. The study seeks to identify markers that differentiate these groups and develop a comprehensive care model for dry eye and Sjgrens Syndrome. Participants will be randomly assigned to one of three groups one receiving laser acupuncture twice a week for 8 weeks, another receiving placebo laser acupuncture for 4 weeks followed by active laser acupuncture for 4 weeks, and a waiting list group receiving no laser acupuncture during the 8 weeks. Laser acupuncture targets specific acupoints on both sides of the body using a device that emits infrared laser at 810 nm, with each point treated for 15 seconds per session. During the study, participants will undergo various assessments including symptom rating scales, eye tests like Schirmers test, patient-reported indexes, and Traditional Chinese Medicine evaluations such as tongue and pulse diagnosis, heart rate variability analysis, microcirculation assessment, and iris examination. These assessments will be done at the end of the 8-week treatment period to measure treatment effects and safety. The trial is designed to last one year for outcome evaluation, aiming for holistic health care development.

Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)