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A Clinical Trial of Acupuncture as Adjuvant Therapy for Glaucoma

Primary Purpose

Glaucoma, Acupuncture, Intraocular Pressure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Acupuncture placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring Glaucoma, Acupuncture

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ophthalmic Acupoint Treatment Group

Non-ophthalmological Acupoint Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Intraocular pressure-Change
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
Best possible vision a an eye can see with corrective lenses, measured in terms of Snellen lines.
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.
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.

Secondary Outcome Measures

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 %.
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.
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 %.
Central corneal thickness
To measure mean values of central corneal thickness (CCT) obtained by specular microscopy.
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.
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 .
Blood pressure
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 the heart rate of patient before and after acupuncture treatment .

Full Information

First Posted
January 29, 2023
Last Updated
March 1, 2023
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05753137
Brief Title
A Clinical Trial of Acupuncture as Adjuvant Therapy for Glaucoma
Official Title
A Clinical Trial of Acupuncture as Adjuvant Therapy for Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 10, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Acupuncture, Intraocular Pressure
Keywords
Glaucoma, Acupuncture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ophthalmic Acupoint Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-ophthalmological Acupoint Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture placebo
Intervention Description
A total of 12 Needles(6 acupoints, bilaterally) will be used in each session. Acupuncture points are different from the experimental group.
Primary Outcome Measure Information:
Title
Intraocular pressure-pre-treatment
Description
Intraocular pressure (IOP) is the fluid pressure of the eye.Tonometer is used for measurement.The unit of value is mmHg.
Time Frame
Every weeks pre-acupuncture treatment up to six weeks.
Title
Intraocular pressure-after-treatment
Description
Intraocular pressure (IOP) is the fluid pressure of the eye.Tonometer is used for measurement.The unit of value is mmHg.
Time Frame
Every weeks after acupuncture treatment up to six weeks.
Title
Intraocular pressure-Change
Description
Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg.
Time Frame
Change from baseline intraocular pressure at 12 weeks.
Title
Best corrected visual acuity
Description
Best possible vision a an eye can see with corrective lenses, measured in terms of Snellen lines.
Time Frame
Change from baseline best corrected visual acuity at 12 weeks.
Title
Visual field- mean deviation
Description
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.
Time Frame
Change from baseline visual field at 12 weeks.
Title
Visual field- visual field index
Description
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.
Time Frame
Change from baseline visual field at 12 weeks.
Secondary Outcome Measure Information:
Title
Optical coherence tomography-RNFL symmety
Description
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 %.
Time Frame
Change from baseline RNFL symmety at 12 weeks.
Title
Optical coherence tomography-C/D ratio
Description
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.
Time Frame
Change from baseline C/D ratio at 12 weeks.
Title
Optical coherence tomography angiography-RPC density
Description
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 %.
Time Frame
Change from baseline RPC density at 6 weeks.
Title
Central corneal thickness
Description
To measure mean values of central corneal thickness (CCT) obtained by specular microscopy.
Time Frame
On the first and 12th week for baseline and follow up tracing.
Title
Glaucoma Symptom Scale
Description
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.
Time Frame
On the first and 12th week for baseline and follow up tracing.
Title
Glaucoma Quality of Life - 15
Description
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 .
Time Frame
On the first and 12th week for baseline and follow up tracing.
Title
Blood pressure
Description
We measure the blood pressure of patient before and after acupuncture treatment .Both systolic and diastolic blood pressure will be measured.
Time Frame
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.
Title
Heart rate
Description
We measure the heart rate of patient before and after acupuncture treatment .
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LEE YU-CHEN, Ph.D
Phone
886-4-22052121
Ext
1670
Email
d5167@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEE YU-CHEN, Ph.D
Organizational Affiliation
China Medical University, China
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Yu-Chen, Ph.D
Phone
+886-975-682-023
Email
d5167@mail.cmuh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28577860
Citation
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.
Results Reference
result
PubMed Identifier
8695555
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.
Results Reference
result
PubMed Identifier
9008633
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.
Results Reference
result

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A Clinical Trial of Acupuncture as Adjuvant Therapy for Glaucoma

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