Acupuncture for Dry Eye Syndrome
|ClinicalTrials.gov Identifier: NCT00969280|
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : September 20, 2010
Last Update Posted : December 21, 2010
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Device: Standardized Acupuncture Device: Non-acupuncture point shallow penetration acupuncture||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: Standardized Acupuncture group||
Device: Standardized Acupuncture
Acupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks.
According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20*30mm (Dongbang Co., korea) acupuncture needle.
All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes.
|Placebo Comparator: Non-acupoint shallow penetration group||
Device: Non-acupuncture point shallow penetration acupuncture
Acupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks.
Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes.
- Ocular Surface Disease Index : OSDI [ Time Frame: Visit 11 (after 3 weeks from baseline) ]The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.
- Visual Analogue Scale of Self Symptoms [ Time Frame: every visit ]
- Schirmer 1 Test [ Time Frame: visit 1,10 ]
- Tear Film Break-up Time : BUT [ Time Frame: Visit 1, 10 ]
- Medication Quantification Scale (MQS) [ Time Frame: every visit ]
- General Assessment [ Time Frame: visit 11 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969280
|Korea, Republic of|
|Clinical Research Center, Korea institute of oriental medicine|
|Daejeon, Chongchungdo, Korea, Republic of, 302-869|
|Study Director:||Sunmi Choi, doctor||Korea Institute of Oriental Medicine|
|Principal Investigator:||Taehun Kim, Doctor||Korea Institute of Oriental Medicine|
|Principal Investigator:||Mi-suk Shin, Master||Korea Institute of Oriental Medicine|