A Clinical Trial of Acupuncture as Adjuvant Therapy for Glaucoma
Study Details
Study Description
Brief Summary
This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. It is estimated a randomized and double-blind 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. It is estimated a randomized and double-blind 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 randomly divided into two groups：Ophthalmic Acupoint Treatment Group and Non-ophthalmological Acupoint Control Group. Participants will receive once a week, six consecutive weeks of interventions in each group, including identical routine care. 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 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ophthalmic Acupoint Treatment Group 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. |
Other: Acupuncture
The treatment will take place once a week, over six weeks. The needles will placed in the body for 20 minutes. A total of 12 Needles(6 acupoints, bilaterally) will be used in each session.
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| Placebo Comparator: Non-ophthalmological Acupoint Control Group 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), Zusanli(ST36), Xiajuxu(ST39), Sanyinjiao(SP6), 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. |
Other: Acupuncture placebo
A total of 12 Needles(6 acupoints, bilaterally) will be used in each session. Acupuncture points are different from the experimental group.
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Outcome Measures
Primary Outcome Measures
- Intraocular pressure-pre-treatment [Every weeks pre-acupuncture treatment up to six weeks.]
Intraocular pressure (IOP) is the fluid pressure of the eye.Tonometer is used for measurement.The unit of value is mmHg.
- Intraocular pressure-after-treatment [Every weeks after acupuncture treatment up to six weeks.]
Intraocular pressure (IOP) is the fluid pressure of the eye.Tonometer is used for measurement.The unit of value is mmHg.
- Intraocular pressure-Change [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.
- Best corrected visual acuity [Change from baseline best corrected visual acuity at 12 weeks.]
Best possible vision a an eye can see with corrective lenses, measured in terms of Snellen lines.
- Visual field- mean deviation [Change from baseline visual field at 12 weeks.]
The visual field refers to the total area in which objects can be seen in the side (peripheral) vision as you focus your eyes on a central point. Visual field will measured with automated perimetry.The unit of value is dB.
- Visual field- visual field index [Change from baseline visual field at 12 weeks.]
The visual field refers to the total area in which objects can be seen in the side (peripheral) vision as you focus your eyes on a central point. Visual field will measured with automated perimetry. Visual field index intuitive presentation may underestimate the visual loss.
Secondary Outcome Measures
- Optical coherence tomography-RNFL symmety [Change from baseline RNFL symmety at 12 weeks.]
The optic disk and the RNFL are the principal sites of apparent glaucomatous damage which precedes glaucomatous visual field alterations. RNFL symmety and Retinal nerve fiber layer (RNFL) thickness measurements obtained with Optical coherence tomography employs low-coherence interferometry.The unit of value is %.
- Optical coherence tomography-C/D ratio [Change from baseline C/D ratio at 12 weeks.]
The optic disk and the RNFL are the principal sites of apparent glaucomatous damage which precedes glaucomatous visual field alterations. The cup/disc (C/D) ratio as a standardised method to evaluate the optic nerve obtained with Optical coherence tomography employs low-coherence interferometry.
- Optical coherence tomography angiography-RPC density [Change from baseline RPC density at 6 weeks.]
Optical coherence tomography angiography is a relatively new, non-invasive, dye-free imaging modality that provides a qualitative and quantitative assessment of the vasculature in the retina and optic nerve head. We use OCTA to complement visual field and OCT examinations to diagnose glaucoma, detect progression and evaluate the treatment of acupuncture. Using OCT angiograms, the RPC density was evaluated quantitatively. The unit of value is %.
- Central corneal thickness [On the first and 12th week for baseline and follow up tracing.]
To measure mean values of central corneal thickness (CCT) obtained by specular microscopy.
- Glaucoma Symptom Scale [On the first and 12th week for baseline and follow up tracing.]
The Glaucoma Symptom Scale (GSS) is a simple and brief glaucoma-specific questionnaire aimed at quantifying complaints and functional impairment in patients with glaucoma. We used 1998 version of the Glaucoma Symptom Scale (GSS; Lee et al., 1998) Questionnaire.The items include 10 ocular complaints, for each eye, a 5-level score is generated, ranging from 0 (complaint present and very bothersome) to 4 (complaint absent). This score is then transformed to a 0 to 100 scale, with 0 representing presence of a very bothersome problem and 100 representing absence of a problem.
- Glaucoma Quality of Life - 15 [On the first and 12th week for baseline and follow up tracing.]
The GQL-15 questionnaire is composed of 15 items. A 5-point rating scale for the level of difficulty of each task totals a score from 0 to 75. A higher score signifies a poorer .
- 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.]
We measure the blood pressure of patient before and after acupuncture treatment .Both systolic and diastolic blood pressure will be measured.
- 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.]
We measure the heart rate of patient before and after acupuncture treatment .
Eligibility Criteria
Criteria
Inclusion Criteria:
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Open angel glaucoma diagnosed at least 3 months ago.
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Diagnosed with mild or moderate open angel glaucoma.
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Use 1 or 2 kinds of glaucoma drugs.
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female or male.
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Age ≥ 20 years old.
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Participants sign the informed consent and cooperate with the experimental procedures.
Exclusion Criteria:
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Accept any ophthalmic laser or surgery within one year.
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High myopia.
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Use of any drugs that affect intraocular pressure.
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Visual acuity with correction lower than 0.2.
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Previous or existing uveitis or retinopathy.
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Unable to receive acupuncture treatment continuously or allergic to acupuncture needles.
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Pregnancy or breastfeeding.
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Refusal to sign the informed consent form.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China Medical University Hospital | Taichung | Taiwan |
Sponsors and Collaborators
- China Medical University Hospital
Investigators
- Study Director: LEE YU-CHEN, Ph.D, China Medical University, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMUH111-REC3-210