NCT03204903

Brief Summary

Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

May 21, 2017

Last Update Submit

August 2, 2018

Conditions

Dry Eye

Keywords

Dry eyeLaser acupunctureTraditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

  • Ocular Surface Disease Index

    The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision.

    12 weeks

Secondary Outcomes (3)

  • Schirmer test

    12 weeks

  • Visual analogue scale of eye discomfort

    12 weeks

  • Tear film break-up time

    12 weeks

Study Arms (2)

Laser acupuncture

EXPERIMENTAL

The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using laser acupuncture during 3 sessions per week for 12 weeks.

Procedure: Laser acupuncture

Sham laser acupuncture

SHAM COMPARATOR

The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using sham laser acupuncture (without laser output) during 3 sessions per week for 12 weeks.

Procedure: Sham laser acupuncture

Interventions

Laser acupuncturePROCEDURE

Subjects were treated 3 times per week for 12 weeks with the LaserPen (GaAlAs laser diode, 810 nm, 150 mW, pulsed waves), which delivered 0.375 J of energy (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.

Laser acupuncture
Sham laser acupuncturePROCEDURE

Subjects were treated 3 times per week for 12 weeks with the LaserPen without laser output (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.

Sham laser acupuncture

Eligibility Criteria

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

You may qualify if:

  • \< age \< 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent.
  • Tear film break-up time \< 10 s
  • Schirmer's strips with anesthesia \< 5mm/ 5min

You may not qualify if:

  • presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens
  • pregnancy, diabetes mellitus, vitamin A deficiency, sequelae of Bell's palsy, hemodialysis
  • critical illness such as Stevens-Johnson syndrome, etc
  • has taken or needs active treatment (including Chinese medicine)
  • presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin
  • does not meet the physician's assessment for recruitment
  • lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (3)

  • Shin MS, Kim JI, Lee MS, Kim KH, Choi JY, Kang KW, Jung SY, Kim AR, Kim TH. Acupuncture for treating dry eye: a randomized placebo-controlled trial. Acta Ophthalmol. 2010 Dec;88(8):e328-33. doi: 10.1111/j.1755-3768.2010.02027.x. Epub 2010 Nov 10.

    PMID: 21070615BACKGROUND

  • Hu WL, Yu HJ, Pan LY, Wu PC, Pan CC, Kuo CE, Tseng YJ, Hung YC. Laser Acupuncture Improves Tear Film Stability in Patients with Dry Eye Disease: A Two-Center Randomized-Controlled Trial. J Altern Complement Med. 2021 Jul;27(7):579-587. doi: 10.1089/acm.2020.0524. Epub 2021 Apr 27.

    PMID: 33904792DERIVED

  • Hu WL, Wu PC, Pan LY, Yu HJ, Pan CC, Hung YC. Effect of laser acupuncture on dry eye: A study protocol for a 2-center randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10875. doi: 10.1097/MD.0000000000010875.

    PMID: 29851803DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Wen-Long Hu, MD, MS

CONTACT

+886-7-7317123oolonghu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Sham laser acupuncture: laser acupuncture without laser output.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2017

First Posted

July 2, 2017

Study Start

August 1, 2016

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)