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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753137
• Other study ID #: CMUH111-REC3-210
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: June 27, 2025

Study information

• Verified date: February 2024
• Source: China Medical University Hospital
• Contact: LEE YU-CHEN, Ph.D
• Phone: 886-4-22052121
• Email: d5167[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 27, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Glaucoma
• Intraocular Pressure

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Glaucoma Quality of Life - 15	The GQL-15 questionnaire is composed of 15 items. A 5-point rating scale for the level of dif?culty of each task totals a score from 0 to 75. A higher score signi?es a poorer .	On the first and 12th week for baseline and follow up tracing.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.