Effects and safety of press-needle therapy for improving visual function and eye blood circulation in glaucoma patients with controlled IOP: Study protocol for a multi-centre randomized controlled trial

Abstract

Abstract Background: Glaucoma causes persistent and increasing deterioration of visual function since it is an untreatable, irreversible condition that causes vision loss. Optic nerve protection is an important treatment for glaucoma with controlled intraocular pressure (GPCI), but to date, there is no universally accepted effective optic nerve protection agent. Acupuncture can protect the optic nerve by increasing blood flow to the eye. However, fear of pain or the limitations of treatment place and time lead to poor patient compliance. Press-needle therapy is a characteristic of traditional Chinese medicine (TCM) external treatment methods; its safety is high, the effect is fast and lasting, it is easy to operate, and it has high patient compliance. Therefore, the aim of this study protocol is to evaluate the safety and effect of press-needle therapy in patients with GPCI. Methods: One hundred and ninety-two participants aged 18 to 75 years with GPCI will be recruited from the Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, MianYang Hospital of TCM and Mianyang Wanjiang Eye Hospital. All participants will be allocated to two treatment groups, including the experimental group or sham press-needle group, at a ratio of 1:1 and will receive press-needle and comfort needle, respectively, for the same 4-week period. The primary outcomes will include best-corrected visual acuity (BCVA), optical coherence tomography angiography (OCTA), colour Doppler flow imaging (CDFI), and visual field assessment; the secondary outcomes will include intraocular pressure (IOP) and traditional Chinese medicine (TCM) clinical symptom scales. The primary outcomes and safety assessments will be measured at baseline and 4 weeks thereafter, and the secondary outcomes will be measured at baseline and 1, 2, 3, and 4 weeks thereafter. Discussion: The results of this research will provide substantial evidence regarding the efficacy of press-needle therapy in improving visual function and eye blood circulation in GPCI patients. Trial registration: ClinicalTrials.gov, ChiCTR2300067862. Registered on 29 January 2023