NCT04157530

Brief Summary

The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

March 12, 2018

Last Update Submit

November 7, 2019

Conditions

GlaucomaAcupuncture

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    Primary outcome measure was the changes of intraocular pressure,

    20 min, twice/week for 2 weeks

Study Arms (3)

sham group

SHAM COMPARATOR

15 subjects with seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints

Device: wang-bu-liu-xing

acupuncture group

EXPERIMENTAL

15 subjects with acupuncture applied to Qingming and Qiuhou with Der-qi

Device: acupuncture

Electroacupuncture group

EXPERIMENTAL

15 subjects wth acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi

Device: Electroacupuncture

Interventions

wang-bu-liu-xingDEVICE

wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints

Also known as: Canon Pneumotonometer
sham group
acupunctureDEVICE

acupuncture applied to Qingming and Qiuhou with Der-qi

acupuncture group
ElectroacupunctureDEVICE

acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch

Electroacupuncture group

Eligibility Criteria

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

You may qualify if:

  • Glaucoma for at least three months
  • Do not use ocular hypotensive drugs or use only one ocular hypotensive drug.
  • It is over 20 years old.
  • Men and women are informal.
  • There is no evidence other than glaucoma that shows other eye diseases.
  • Be aware and fill out the consent form yourself.

You may not qualify if:

  • Combines other chronic diseases, taking multiple medications such as high blood pressure, diabetes, etc.
  • Those who have had glaucoma surgery.
  • Those who had undergone myopia laser surgery.
  • Can not accept acupuncture points stimulators.
  • Allergic to acupuncture needles.
  • Has a mental illness or is unable to cooperate with the researcher.
  • Do not sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (2)

  • Mac Nair CE, Nickells RW. Neuroinflammation in Glaucoma and Optic Nerve Damage. Prog Mol Biol Transl Sci. 2015;134:343-63. doi: 10.1016/bs.pmbts.2015.06.010. Epub 2015 Jul 10.

    PMID: 26310164RESULT

  • Chen SY, Yieh FS, Liao WL, Li TC, Hsieh CL. Effect of Acupuncture on Intraocular Pressure in Glaucoma Patients: A Single-Blinded, Randomized, Controlled Trial. Evid Based Complement Alternat Med. 2020 Apr 28;2020:7208081. doi: 10.1155/2020/7208081. eCollection 2020.

    PMID: 32419820DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Acupuncture TherapyElectroacupuncture

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Ching-Liang Hsieh, PhD

    China Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

November 8, 2019

Study Start

March 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)