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Laser Acupuncture for Dry Eye

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture
Sham laser acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, Laser acupuncture, Traditional Chinese medicine

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser acupuncture

Sham laser acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 21, 2017
Last Updated
August 2, 2018
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03204903
Brief Title
Laser Acupuncture for Dry Eye
Official Title
Laser Acupuncture Therapy in Patients With Dry Eye: A Two-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry eye, Laser acupuncture, Traditional Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Sham laser acupuncture: laser acupuncture without laser output.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham laser acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laser acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham laser acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Schirmer test
Description
A Schirmer's test is used to assess how quickly the eyes produce tears.
Time Frame
12 weeks
Title
Visual analogue scale of eye discomfort
Description
A 10-cm visual analog scale (0-10 points, least to greatest discomfort intensity, VAS) was used to measure the intensity of eye discomfort.
Time Frame
12 weeks
Title
Tear film break-up time
Description
Tear film break-up time (TFBUT) measures the time required for tears to naturally evaporate and diffuse after blinking.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Long Hu, MD, MS
Phone
+886-7-7317123
Ext
6255
Email
oolonghu@gmail.com
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Long Hu, MD, MS
Phone
+886-7-7317123
Ext
6255
Email
oolonghu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21070615
Citation
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.
Results Reference
background
PubMed Identifier
33904792
Citation
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.
Results Reference
derived
PubMed Identifier
29851803
Citation
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.
Results Reference
derived

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Laser Acupuncture for Dry Eye

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