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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Intraocular Pressure; Acupuncture
• Intervention / Treatment: Other: Acupuncture; Other: Acupuncture placebo

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LEE YU-CHEN, Ph.D; Phone Number: 1670 886-4-22052121; Email: d5167@mail.cmuh.org.tw

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Contact: Lee Yu-Chen, Ph.D; Phone Number: +886-975-682-023; Email: d5167@mail.cmuh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. female or male.
5. Age ≥ 20 years old.
6. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation.
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), 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.	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.The control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Intraocular pressure-pre-treatment	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.	Every weeks pre-acupuncture treatment up to six weeks.
Intraocular pressure-after-treatment	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.	Every weeks 15 minutes after acupuncture treatment up to six weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Study Director: LEE YU-CHEN, Ph.D, China Medical University, China

Publications and helpful links

General Publications

• 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.
• Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): June 27, 2025
• Study Completion (Estimated): June 27, 2025

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acupuncture; Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: CMUH111-REC3-210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No