Currently submitted to: JMIR Research Protocols
Date Submitted: Feb 29, 2024
Open Peer Review Period: Mar 1, 2024 - Apr 26, 2024
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Acupuncture as Adjuvant Therapy for Glaucoma : Protocol for a Randomized Controlled Trial.
ABSTRACT
Background:
Introduction：Glaucoma is a chronic progressive optic neuropathy that necessitates lifelong treatment to retard the decline of the optic nerve. Due to the extended and continuous treatments required for patients, they may explore alternative or complementary therapies alongside conventional treatments to enhance the effectiveness in controlling disease progression. Acupuncture has displayed promise in the treatment of various ophthalmic disorders in clinical trials, and its potential to reduce intraocular pressure (IOP) makes it an intriguing candidate for managing glaucoma.
Objective:
The primary objective of this trial is to conduct a single-center clinical trial involving glaucoma patients, wherein acupuncture will be evaluated as an adjunctive therapy, aiming to explore its effectiveness for glaucoma.
Methods:
In this single-center, randomized, controlled trial, 50 patients diagnosed with primary open-angle glaucoma will be randomly allocated to two groups: the treatment group and the control group. Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation. Conversely, the control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation. Both groups will undergo acupuncture therapy once a week for a total of six sessions and will be observed for twelve weeks. The primary outcome will be the variation in IOP before and after each acupuncture session. Secondary outcomes will encompass pre- and post-acupuncture measurements of heart rate and blood pressure. Additionally, assessments will be conducted for best-corrected visual acuity, visual field, optical coherence tomography (OCT), OCT-angiography, glaucoma symptom scale, and the glaucoma quality of life-15 questionnaire, with comparisons made against baseline measurements.
Results:
Ethics approval was obtained from the institutional review board of China Medical University Hospital (CMUH111-REC3-210), and was registered on clinicaltirl.gov (NCT05753137). Recruitment of participants for the trial commenced on June 28, 2023, and currently, only a limited number of participants have been enrolled to test the feasibility of the experiment. We anticipate that the preliminary data from this trial will be completed by 2025.
Conclusions:
This trial employs rigorous methodology and comprehensive outcome measurements to assess the clinical efficacy of acupuncture as an adjunctive therapy for glaucoma, providing valuable insights for future clinical treatment guidelines. Clinical Trial: ClinicalTrials.gov NCT05753137, registered on 2023/01/29
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