Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma

NCT05247762 | Completed

• 1 other identifier: CMUH110-REC2-225
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the therapeutic effect of acupuncture at the Jingming and the Qiuhou acupoints on the visual acuity and visual field in patients with primary open-angle glaucoma. Participants will get acupuncture or Wangbuliu Xingzi Paste (sham acupuncture) on both sides of the Jingming and the Qiuhou, once a week, once for 20 minutes, for 24 weeks. Researchers will compare acupuncture group and sham acupuncture group to see if the visual acuity, visual field, intraocular pressure, optic nerve fiber layer thickness, serum homocysteine concentration, and scores on the WHOQOL-REF (Taiwan version) scale would be improved.

Conditions

Primary Open-angle Glaucoma

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (2)

• visual acuity

  Primary outcome measure was the changes of visual acuity

  24 weeks

• visual field

  Primary outcome measure was the changes of visual field

  24 weeks

Secondary Outcomes (4)

• intraocular pressure

  24 weeks

• optic nerve fiber layer thickness

  24 weeks

• serum homocysteine concentration

  24 weeks

• the World Health Organization Quality of Life brief (Taiwan version) scale

  24 weeks

Study Arms (2)

Sham acupuncture group

SHAM COMPARATOR

Use Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks.

Device: Acupuncture

Acupuncture group

EXPERIMENTAL

Use stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks.

Device: Acupuncture

Interventions

Acupuncture DEVICE

The stainless steel needles are used to insert into the two points of Jingming and the Qiuhou, and der-qi, once a week, once for 20 minutes, for 24 consecutive weeks.

Acupuncture group; Sham acupuncture group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open-angle glaucoma diagnosis at least 3 months previously.
• Use of one or no intraocular hypotensive drugs.
• There is no evidence of other eye diseases other than glaucoma.
• Clear consciousness that enabled the participant to sign the informed consent form and cooperate with the trial procedure.

You may not qualify if:

• Comorbidity with other chronic diseases, such as hypertension and diabetes, and taking multiple drugs.
• Laser surgery for either glaucoma or myopia.
• Pregnancy or lactation.
• Intolerance to acupuncture treatment.
• Allergy to acupuncture needles.
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, North District, 40447, Taiwan

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ching-Liang Hsieh, Ph.D

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: February 28, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)