Laser Acupuncture for Dry Eye

August 2, 2018 updated by: Chang Gung Memorial Hospital

Laser Acupuncture Therapy in Patients With Dry Eye: A Two-center Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: Dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. The investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye.

Methods: 200 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20 < 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laser acupuncture
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
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.
SHAM_COMPARATOR: Sham laser acupuncture
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer test
Time Frame: 12 weeks
A Schirmer's test is used to assess how quickly the eyes produce tears.
12 weeks
Visual analogue scale of eye discomfort
Time Frame: 12 weeks
A 10-cm visual analog scale (0-10 points, least to greatest discomfort intensity, VAS) was used to measure the intensity of eye discomfort.
12 weeks
Tear film break-up time
Time Frame: 12 weeks
Tear film break-up time (TFBUT) measures the time required for tears to naturally evaporate and diffuse after blinking.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ANTICIPATED)

July 31, 2019

Study Completion (ANTICIPATED)

July 31, 2019

Study Registration Dates

First Submitted

May 21, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8F0551
  • 201600333A3 (OTHER: Chang Gung Medical Foundation Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye

Clinical Trials on Laser acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe