NCT05753137

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

January 29, 2023

Last Update Submit

June 30, 2024

Conditions

GlaucomaAcupunctureIntraocular Pressure

Keywords

GlaucomaAcupuncture

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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 Outcomes (11)

  • Optical coherence tomography-RNFL symmety

    Change from baseline RNFL symmety at 12 weeks.

  • Optical coherence tomography-C/D ratio

    Change from baseline C/D ratio at 12 weeks.

  • Optical coherence tomography angiography-RPC density

    Change from baseline RPC density at 6 weeks.

  • Central corneal thickness

    On the first and 12th week for baseline and follow up tracing.

  • Glaucoma Symptom Scale

    On the first and 12th week for baseline and follow up tracing.

  • +6 more secondary outcomes

Study Arms (2)

Ophthalmic Acupoint Treatment Group

EXPERIMENTAL

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

Non-ophthalmological Acupoint Control Group

PLACEBO COMPARATOR

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

Interventions

AcupunctureOTHER

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.

Ophthalmic Acupoint Treatment Group
Acupuncture placeboOTHER

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.

Non-ophthalmological Acupoint Control Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary open angle glaucoma diagnosed at least 3 months ago.
  • Diagnosed with mild or moderate open angel glaucoma.
  • Use 1 or 2 kinds of glaucoma drugs.
  • Age ≥ 20 years old.
  • Participants sign the informed consent and cooperate with the experimental procedures.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28577860RESULT

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

    PMID: 8695555RESULT

  • 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.

    PMID: 9008633RESULT

  • Liao YF, Lee YC, Lin HJ, Shao YC. Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 8;13:e57888. doi: 10.2196/57888.

    PMID: 39378079DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • LEE YU-CHEN, Ph.D

    China Medical University, China

    STUDY DIRECTOR

Central Study Contacts

LEE YU-CHEN, Ph.D

CONTACT

886-4-22052121d5167@mail.cmuh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2023

First Posted

March 3, 2023

Study Start

June 28, 2023

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)