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Abstract
BackgroundPrevious studies of acupuncture show favourable results for both subjective and objective outcomes of dry eye. However, firm conclusions could not be drawn from these studies because the quality of the trials was too low to establish concrete evidence. Therefore, this study was designed both to avoid the flaws of the existing trials and to assess the effectiveness, cost-effectiveness and qualitative characteristics of acupuncture treatment for dry eye.Methods/designOne hundred fifty participants with dry eye will be recruited into three independent hospitals from different areas: Korea Institute of Oriental Medicine, DongGuk University Ilsan Oriental Hospital and Dongshin University Gwangju Oriental Hospital. The number of participants required was calculated from the data of a previous, relevant study. These patients will be randomly allocated into acupuncture treatment or artificial tear groups. Either 17 acupuncture points (bilateral BL2, GB14, TE 23, Ex1, ST1, GB20, LI4, LI11 and single GV23) will be used 3 times a week or disposable artificial tear drops (Refresh Plus®, ALLERGAN) will be provided for use at least once a day for 4 weeks. The ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer I test, visual analogue scale (VAS) for self-assessment of ocular discomfort, general assessment (by both acupuncture practitioners and participants) and quality of life (QOL) through the Measure Yourself Medical Outcome Profile-2 (MYMOP-2) will be assessed for approximately 3-months for each study participant. In addition, qualitative study and cost-effectiveness of acupuncture treatment will be conducted.Trial registrationClinicalTrials.gov (Identifier: NCT01105221).
Highlights
Previous studies of acupuncture show favourable results for both subjective and objective outcomes of dry eye
Because of recent data on both the pathological mechanism and aetiology, the definition of dry eye has been changed from simple ocular discomfort to a multifactorial disease [1]
Acupuncture is a widely used treatment modality for various conditions, including ophthalmologic diseases [4]. It is generally accepted as an effective treatment option in clinical practices
Summary
Dry eye is not a life-threatening disease, but it is one of the most common and irritating conditions in ophthalmology. Acupuncture practitioners and participants will evaluate general improvement of dry eye-related symptoms using a five-grade scale: excellent, good, fair, poor and aggravation This will be assessed after the end of the treatment period (the fifth week). Additional study A nested, questionnaire-based, qualitative study will be conducted to explore the participants’ reason for enrolling in this randomized controlled trial, experiences of dry-eye, and perceived changes after either acupuncture or artificial tear drop treatment. List of abbreviations ANCOVA: analysis of covariance; CRA: clinical research associate; CRF: clinical record form; IRB: the institutional review board; LOCF: last observation carried forward; MYMOP-2: Measure Yourself Medical Outcome Profile-2; OSDI: ocular surface disease index; TFBUT: tear film break-up time; VAS: visual analogue scale; QOL: quality of life
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