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
CRIS Registration Number |
KCT0000727 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Daejeon Technopark |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
7. Study Summary
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 . |
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8. Study Design
Study Type | Interventional Study |
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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 |
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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
Condition(s)/Problem(s) |
* (H00-H59)Diseases of the eye and adnexa (H52.1)Myopia |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Ocular Surface Disease Index (OSDI) |
|
Timepoint | visit 2 before acupuncture treatment, visit 8, visit 14 and visit 15 |
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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 |
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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 |
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Secondary Outcome(s) 7 | ||
Outcome | General assessment |
|
Timepoint | visit 14 |
11. Study Results and Publication
Result Registered | Yes |
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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 Statement | Not provided at time of Registration |
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