Clinical trial NCT05753137: Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial
Official title: Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Acupuncture
Intraocular Pressure
Keywords: Glaucoma
Acupuncture
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular pressure-pre-treatment
timeFrame: Every weeks pre-acupuncture treatment up to six weeks.
measure: Intraocular pressure-after-treatment
timeFrame: Every weeks 15 minutes after acupuncture treatment up to six weeks.
measure: Intraocular pressure-Change
timeFrame: Change from baseline intraocular pressure at 12 weeks.
Secondary outcomes:
measure: Optical coherence tomography-RNFL symmety
timeFrame: Change from baseline RNFL symmety at 12 weeks.
measure: Optical coherence tomography-C/D ratio
timeFrame: Change from baseline C/D ratio at 12 weeks.
measure: Optical coherence tomography angiography-RPC density
timeFrame: Change from baseline RPC density at 6 weeks.
measure: Central corneal thickness
timeFrame: On the first and 12th week for baseline and follow up tracing.
measure: Glaucoma Symptom Scale
timeFrame: On the first and 12th week for baseline and follow up tracing.
measure: Glaucoma Quality of Life - 15
timeFrame: On the first and 12th week for baseline and follow up tracing.
measure: Blood pressure
timeFrame: we measure blood pressure every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing.
measure: Heart rate
timeFrame: we measure heart rate every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing.
measure: Best corrected visual acuity
timeFrame: Change from baseline best corrected visual acuity at 12 weeks.
measure: Visual field- mean deviation
timeFrame: Change from baseline visual field at 12 weeks.
measure: Visual field- visual field index
timeFrame: Change from baseline visual field at 12 weeks.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: LEE YU-CHEN, Ph.D
role: STUDY_DIRECTOR
References:
citation: Jonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017 Nov 11;390(10108):2183-2193. doi: 10.1016/S0140-6736(17)31469-1. Epub 2017 May 31.
citation: Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.
citation: Quigley HA, Vitale S. Models of open-angle glaucoma prevalence and incidence in the United States. Invest Ophthalmol Vis Sci. 1997 Jan;38(1):83-91.