Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial

China Medical University

Status: Enrolling

Conditions: Glaucoma; Acupuncture; Intraocular Pressure

Treatments: Other: Acupuncture placebo; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05753137

CMUH111-REC3-210

Details and patient eligibility

About

This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. A randomized, controlled trial involving 50 subjects will be conducted and observed for 12 weeks to evaluate the clinical efficacy of acupuncture. This study aims to provide a reference for future clinical treatment guidelines.

Full description

This clinical trial utilized acupuncture as an adjunctive treatment for glaucoma patients. It is estimated a randomized clinical trial that 50 subjects will be enrolled and observed for 12 weeks to evaluate the clinical efficacy of acupuncture, providing a reference for future clinical treatment guidelines. Participants will be randomly divided into two groups: Ophthalmic Acupoint Treatment Group and Non-ophthalmological Acupoint 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. On each visit, intraocular pressure, blood pressure, and heart rate will be assessed. Questionnaires of Glaucoma Symptom Scale (GSS) and The Glaucoma Quality of Life-15 (GQL-15) will be performed. The data of central corneal thickness, optical coherence tomography angiography, optical coherence tomography, visual field, and best-corrected visual acuity will be collected and analyzed before acupuncture and in the 12th week.

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primary open angle glaucoma diagnosed at least 3 months ago.
2. Diagnosed with mild or moderate open angel glaucoma.
3. Use 1 or 2 kinds of glaucoma drugs.
4. Age ≥ 20 years old.
5. Participants sign the informed consent and cooperate with the experimental procedures.

Exclusion criteria

1. Accept any ophthalmic laser or surgery within one year.
2. High myopia.
3. Use of any drugs that affect intraocular pressure.
4. Visual acuity with correction lower than 0.2.
5. Previous or existing uveitis or retinopathy.
6. Unable to receive acupuncture treatment continuously or allergic to acupuncture needles.
7. Pregnancy or breastfeeding.
8. Refusal to sign the informed consent form.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Ophthalmic Acupoint Treatment Group

Experimental group

Description:

Ophthalmic acupoint treatment group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time. Acupuncture points: Fengchi(GB20), Cuanzhu(BL2), Sibai(ST2), Taiyang(EX-HN5), Hegu(LI4), Taichong(LR3), a total of six acupoints.

Treatment:

Other: Acupuncture

Non-ophthalmological Acupoint Control Group

Placebo Comparator group

Description:

Non-ophthalmological acupoint control group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time. Acupuncture points: Yinlingquan(SP9), Liangqiu (ST34),Xiajuxu(ST39), Yanglingquan (GB34), Shousanli(LI10), Sanyangluo(TE8), a total of six acupoints. The Non-ophthalmological acupoint control group points are not indicated for the treatment of ophthalmological related pathologies, and are not reported to improve ophthalmological function.

Treatment:

Other: Acupuncture placebo