A Clinical Trial of Acupuncture as Adjuvant Therapy for Glaucoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Trial of Acupuncture as Adjuvant Therapy for Glaucoma

Conditions
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Glaucoma, Acupuncture, Intraocular Pressure

Intervention / Treatment
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* Other: Acupuncture
* Other: Acupuncture placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open angel glaucoma diagnosed at least 3 months ago. Diagnosed with mild or moderate open angel glaucoma. Use 1 or 2 kinds of glaucoma drugs. female or male. 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 0.2. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ophthalmic Acupoint Treatment Group<br>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<br>* 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.<br>|
| Placebo Comparator: Non-ophthalmological Acupoint Control Group<br>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<br>* A total of 12 Needles(6 acupoints, bilaterally) will be used in each session. Acupuncture points are different from the experimental group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure-pre-treatment | Intraocular pressure (IOP) is the fluid pressure of the eye.Tonometer is used for measurement.The unit of value is mmHg. | Every weeks pre-acupuncture treatment up to six weeks. | 
| Intraocular pressure-after-treatment | Intraocular pressure (IOP) is the fluid pressure of the eye.Tonometer is used for measurement.The unit of value is mmHg. | Every weeks after acupuncture treatment up to six weeks. | 
| Intraocular pressure-Change | Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg. | Change from baseline intraocular pressure at 12 weeks. | 
| Best corrected visual acuity | Best possible vision a an eye can see with corrective lenses, measured in terms of Snellen lines. | Change from baseline best corrected visual acuity at 12 weeks. | 
| Visual field- mean deviation | 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. | Change from baseline visual field at 12 weeks. | 
| Visual field- visual field index | 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. | Change from baseline visual field at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography-RNFL symmety | 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 %. | Change from baseline RNFL symmety at 12 weeks. | 
| Optical coherence tomography-C/D ratio | 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. | Change from baseline C/D ratio at 12 weeks. | 
| Optical coherence tomography angiography-RPC density | 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 %. | Change from baseline RPC density at 6 weeks. | 
| Central corneal thickness | To measure mean values of central corneal thickness (CCT) obtained by specular microscopy. | On the first and 12th week for baseline and follow up tracing. | 
| Glaucoma Symptom Scale | 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. | On the first and 12th week for baseline and follow up tracing. | 
| Glaucoma Quality of Life - 15 | 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 . | On the first and 12th week for baseline and follow up tracing. | 
| Blood pressure | We measure the blood pressure of patient before and after acupuncture treatment .Both systolic and diastolic blood pressure will be measured. | 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 the heart rate of patient before and after acupuncture treatment . | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Acupuncture