Effects and Safety of Press-Needle Therapy for Improving Visual Function and Eye Blood Circulation in Patients With Glaucoma With Controlled Intraocular Pressure: Study Protocol for a Multicenter Randomized Controlled Trial.

Abstract

Background: Glaucoma is the leading cause of irreversible blindness worldwide, causing continuous and progressively worsening damage to visual function, which leads to 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 conduct, and it has high patient compliance.

Objective: The objective of the trial is to evaluate the safety and clinical efficacy of press-needle therapy and investigate whether it can improve visual function by regulating eye blood circulation in patients with GPCI.

Methods: In total, 192 participants aged 18-75 years with GPCI from the Mianyang Central Hospital, the Mianyang Hospital of Traditional Chinese Medicine, and the Mianyang Wanjiang Eye Hospital will participate in this study. Participants will be allocated to 2 treatment groups (experimental and control groups) in a ratio of 1:1 and will undergo press-needle therapy and sham press-needle therapy, respectively, for the same 4-week period. Primary outcomes will include the best-corrected visual acuity (BCVA), optical coherence tomography angiography (OCTA), color Doppler flow imaging (CDFI), and visual field assessment results. Secondary outcomes will include the 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, while the secondary outcomes will be measured at baseline and 1, 2, 3, and 4 weeks thereafter.

Results: Recruitment and data collection began in February 2023. The final outcomes are expected in September 2025. As of October 2024, the project had recruited 220 eligible participants, of whom 192 (87.3%) will complete the study, exceeding initial projections for the study time frame. The remainder of the participants will provide the ability to explore cross-level interactions that could not be statistically powered at the outset. The strengths of the project include rigorous data collection, good retention rates, and high compliance rates.

Conclusions: This study will provide data on the effects of press-needle therapy on visual function and ocular circulation in patients with GPCI, and these results will help demonstrate whether acupuncture can improve patients' visual function by regulating ocular circulation, thus providing a clinical and theoretical basis for the wider application of acupuncture therapy in GPCI.

Trial registration: Chinese Clinical Trial Registry ChiCTR2300067862；https://tinyurl.com/mrxd58x9.

International registered report identifier (irrid): DERR1-10.2196/67737.