Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Intraocular pressure-pre-treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary open angle glaucoma diagnosed at least 3 months ago.
- •Diagnosed with mild or moderate open angel glaucoma.
- •Use 1 or 2 kinds of glaucoma drugs.
- •Age ≥ 20 years old.
- •Participants sign the informed consent and cooperate with the experimental procedures.
Exclusion Criteria
- •Accept any ophthalmic laser or surgery within one year.
- •High myopia.
- •Use of any drugs that affect intraocular pressure.
- •Visual acuity with correction lower than 0.
- •Previous or existing uveitis or retinopathy.
- •Unable to receive acupuncture treatment continuously or allergic to acupuncture needles.
- •Pregnancy or breastfeeding.
- •Refusal to sign the informed consent form.
Outcomes
Primary Outcomes
Intraocular pressure-pre-treatment
Time Frame: Every weeks pre-acupuncture treatment up to six weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Intraocular pressure-after-treatment
Time Frame: Every weeks 15 minutes after acupuncture treatment up to six weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Intraocular pressure-Change
Time Frame: Change from baseline intraocular pressure at 12 weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg.
Secondary Outcomes
- Visual field- mean deviation(Change from baseline visual field at 12 weeks.)
- Optical coherence tomography angiography-RPC density(Change from baseline RPC density at 6 weeks.)
- Optical coherence tomography-C/D ratio(Change from baseline C/D ratio at 12 weeks.)
- Best corrected visual acuity(Change from baseline best corrected visual acuity at 12 weeks.)
- Visual field- visual field index(Change from baseline visual field at 12 weeks.)
- Glaucoma Quality of Life - 15(On the first and 12th week for baseline and follow up tracing.)
- Blood pressure(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.)
- Heart rate(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.)
- Optical coherence tomography-RNFL symmety(Change from baseline RNFL symmety at 12 weeks.)
- Central corneal thickness(On the first and 12th week for baseline and follow up tracing.)
- Glaucoma Symptom Scale(On the first and 12th week for baseline and follow up tracing.)