Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 20, 2024
Date Accepted: Mar 7, 2025
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
Background:
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.
Objective:
The objective of the trial is to evaluate the clinical efficacy of press-needle and to investigate whether it can improve visual function by regulating eye blood circulation in patients with GPCI.
Methods:
The objective of the trial is to evaluate the clinical efficacy of press-needle and to investigate whether it can improve visual function by regulating eye blood circulation in patients with GPCI.
Results:
Recruitment and data collection began in February 2023 and continued through March 2024. Final outcome are expected in March 2025. As of October 2024, the project had recruited 220 eligible participants, of whom 192 (87.3%) completed the study, exceeding initial projections for the study time frame. The remainder of the recruitment will provide the capacity 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 on visual function and ocular circulation in GPCI patients, and these results will help to demonstrate whether acupuncture can improve GPCI patients’ visual function by regulating ocular circulation, thus providing a clinical and theoretical basis for the wider application of acupuncture therapy in GPCI. Clinical Trial: ClinicalTrials.gov, ChiCTR2300067862；https://www.chictr.org.cn
Citation
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Copyright
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