Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for Randomized Controlled Trial

Background: Glaucoma is a chronic progressive optic neuropathy that necessitates lifelong treatment to reduce the decline ofthe optic nerve. Due to the extended and continuous treatments required for patients, complementary therapies are often consideredalongside conventional treatments to enhance the effectiveness of the treatment. Acupuncture has demonstrated the potential tolower intraocular pressure in previous clinical trials, making it a promising glaucoma intervention. Objective: The primary objective of this study is to conduct a single-center randomized control trial involving patients withglaucoma. Acupuncture will be evaluated as an adjunctive therapy. The trial aims to explore its effectiveness for glaucoma. Methods: In this single-center randomized controlled trial, participants (N=50) with primary open-angle glaucoma will berandomly assigned to the treatment group, receiving ophthalmic acupuncture with "De Qi" sensation, or the control group,receiving minimum acupuncture stimulation on nonophthalmic acupoints. The intervention will consist of weekly acupuncturetreatments for a total of 6 sessions. Participants will be assessed at 8 time points, which are baseline, during the intervention (6times), and at a 3-month follow-up. The primary outcome measure is a change in the intraocular pressure before and after eachacupuncture treatment. Secondary outcomes will include measurements of heart rate and blood pressure before and after acupuncture,best-corrected visual acuity, visual field, optical coherence tomography, optical coherence tomography angiography, the GlaucomaSymptom Scale, and the Glaucoma Quality of Life-15 questionnaire. Results: Recruitment of participants for the trial commenced on June 28, 2023. A total of 10 participants have been enrolledto test the feasibility of the experiment. We anticipate that the preliminary data from this trial will be completed by December2025. Conclusions: This trial uses rigorous methodology and comprehensive outcome measurements to assess the clinical efficacyof acupuncture as an adjunctive therapy for glaucoma, providing valuable insights for future clinical treatment guidelines.