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Acupuncture for dry eye syndrome after myopia correctional surgery: randomized, usual care-controlled pilot trial

Status Approved

  • First Submitted Date

    2012/12/18

  • Registered Date

    2013/04/23

  • Last Updated Date

    2015/03/04

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0000727
    Unique Protocol ID KI1207
    Public/Brief Title Acupuncture for dry eye syndrome after refractive surgery
    Scientific Title Acupuncture for dry eye syndrome after myopia correctional surgery: randomized, usual care-controlled pilot trial
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number djomc-98
    Approval Date 2012-10-19
    Institutional Review Board Name Institutional Review Board at Oriental Hospital of Daejeon University
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jeong-hyo Jo
    Title MD.PhD
    Telephone +82-42-229-6806
    Affiliation Daejeon Korean Medicine Hospital of Daejeon University
    Address
    Contact Person for Public Queries
    Name Jun Hwan Lee
    Title MD.PhD
    Telephone +82-42-868-9693
    Affiliation Korea Institute of Oriental Medicine
    Address
    Contact Person for Updating Information
    Name Jun Hwan Lee
    Title MD.PhD
    Telephone +82-42-868-9693
    Affiliation Korea Institute of Oriental Medicine
    Address
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2013-01-15 Actual
    Target Number of Participant 40
    Primary Completion Date 2013-12-03 , Actual
    Study Completion Date 2013-12-03 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Daejeon Korean Medicine Hospital of Daejeon University
    Recruitment Status Completed
    Date of First Enrollment 2013-01-15 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Daejeon Technopark
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Dry eye is a significantly frequent consequence of myopia correctional surgery. This study is for dry eye syndrome after myopia correctional surgery and is a randomized, controlled pilot trial to compare the acupuncture group with the usual care control group. The acupuncture group will undergo treatments on seventeen acupuncture points, 3 times per week for 4 weeks. The control group will receive only usual care during the same period. This pilot study aims to evaluate the efficacy of acupuncture treatment in treating the signs and symptoms of dry eye syndrome aftermyopia correctional surgery . 
    
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    Seventeen acupuncture points (bilateral BL2,GB14, TE 23, Ex1, ST1, GB20, LI4, and LI11 and single GV23) will be located according to the WHO Standard
    Acupuncture Point Locations in the Western Pacific Region. These will then be treated with 0.20*30 mm disposable acupuncture needles (Dongbang Co., Korea). The ‘deqi’ sensation will be induced by twisting acupuncture and needles will be retained for 20 minutes before removal. Participants will have acupuncture treatments three times per week for four weeks.
    Number of Arms 2
    Arm 1

    Arm Label

    Acupuncture plus usual care group

    Target Number of Participant

    20

    Arm Type

    Experimental

    Arm Description

    Seventeen acupuncture points (bilateral BL2,GB14, TE 23, Ex1, ST1, GB20, LI4, and LI11 and single GV23) will be located according to the WHO Standard
    Acupuncture Point Locations in the Western Pacific Region. These will then be treated with 0.20*30 mm disposable acupuncture needles (Dongbang Co., Korea). The ‘deqi’ sensation will be induced by twisting acupuncture and needles will be retained for 20 minutes before removal. Participants will have acupuncture treatments three times per week for four weeks.
    Arm 2

    Arm Label

    Usual care control group

    Target Number of Participant

    20

    Arm Type

    Active comparator

    Arm Description

    This group will be allowed to use any kind of treatment for dry eye during the followup period except operation.
    - artificial tear drops, drugs, supplements (e.g.cyclosporine,corticosteroids, biological tear substitute, and oestrogen), and alternative treatments.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (H00-H59)Diseases of the eye and adnexa 
       (H52.1)Myopia 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~65Year

    Description

    1. Men and women, 18 to 65 years old
    2. Dry eye syndrome in one or both eyes (ICD-10:H04.1) with:
    2-1. Refractive surgery within 24 months and dry eye symptoms (for example, ocular itching, foreign body sensation, burning, pain and dryness, visual disturbance, ocular redness, and/or a sensation of tearing) of at least moderate severity
    2-2. VAS score ≥ 40
    2-3. TBUT ≤10 seconds and Schirmer-I test results ≤ 10 mm/5 minutes
    3. Voluntary participation and written informed consent
    Exclusion Criteria
    1. Dry eye symptoms due to eyelid or eyelash defects
    2. Acute infection of the eyelid, eyeball or periorbital area
    3. Skin disease such as Stevens-Johnson syndrome and/or pemphigoid
    4. Vitamin A deficiency
    5. Any external injury to the orbital or periorbital area
    6. A history of eye surgery within the past six months (except refractive surgery)
    7. Impaired blinking due to facial palsy
    8. History of punctal plug or punctal occlusion surgery
    9. Pregnancy, lactation, or plans to conceive
    10. Exclusion at the investigator’s discretion
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Ocular Surface Disease Index (OSDI)
    Timepoint
    visit 2 before acupuncture treatment, visit 8, visit 14 and visit 15
    Secondary Outcome(s) 1
    Outcome
    Visual Analogue Scale (VAS)
    Timepoint
    screening visit, visit 2, visit 8, visit 14 and visit 15
    Secondary Outcome(s) 2
    Outcome
    Tear Film Break up Time  (BUT)
    Timepoint
    screening visit and visit 15
    Secondary Outcome(s) 3
    Outcome
    Quality of Life (QOL)
    Timepoint
    visit 2, visit 8, visit 14 and visit 15
    Secondary Outcome(s) 4
    Outcome
    Fluorescein stained corneal surface digital photography
    Timepoint
    screening visit and visit 15
    Secondary Outcome(s) 5
    Outcome
    Schirmer-I test with anesthesia
    Timepoint
    screening visit and visit 15
    Secondary Outcome(s) 6
    Outcome
    Experience about durg or other therapeutic modalities
    Timepoint
    visit 15 
    Secondary Outcome(s) 7
    Outcome
    General assessment
    Timepoint
    visit 14
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Final Enrollment Number
    Number of Publication 1
    Publications 1
    Hyesun Jang, Sanghun Lee, Tae-Hun Kim, Ae-Ran Kim, Minhee Lee and Jun-Hwan Lee. Acupuncture for dry eye syndrome after refractive surgery: study protocol for a randomized controlled trial. TRIALS. SCI. 2013-10-01 ,
    														 VOL : 14 page :  ~ 
    														
    														
    Results Upload
    Date of Posting Results 2013/04/23
    Protocol URL or File Upload
    Brief Summary
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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