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Open Access Study protocol

Acupuncture for dry eye syndrome after refractive surgery: study protocol for a randomized controlled trial

Hyesun Jang1, Sanghun Lee1, Tae-Hun Kim2, Ae-Ran Kim1, Minhee Lee1 and Jun-Hwan Lee1*

Author Affiliations

1 Acupuncture, Moxibustion and Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdaero, Yuseong-gu 305-811, Daejeon, South Korea

2 College of Korean Medicine, Gachon University, Seongnam, South Korea

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Trials 2013, 14:351  doi:10.1186/1745-6215-14-351

Published: 24 October 2013

Abstract

Background

Dry eye syndrome is a frequent complication of refractive surgery. Acupuncture has been widely used to alleviate the associated symptoms. However, the use of acupuncture for patients who suffer from dry eye syndrome following refractive surgery has certain drawbacks. This pilot study aims to evaluate the efficacy of acupuncture treatment in treating the signs and symptoms of dry eye syndrome after refractive surgery.

Methods/design

Forty participants will be randomly assigned to the acupuncture plus usual care group or the usual care control group. The acupuncture plus usual care group will undergo treatments on seventeen acupuncture points, three times per week for four weeks. The control group will receive only usual care during the same period. The primary outcomes will be scores on the Ocular Surface Disease Index (OSDI) and the results of examinations at 1, 3, 5, and 13 weeks. The secondary outcomes will be Tear Film Break-up Time (TBUT), as well as scores on the Schirmer-I test, visual analog scale (VAS), and quality of life (QOL) questionnaire for the self-assessment of ocular discomfort. Digital photographs will be taken to document the pattern of fluorescein staining observed on the corneal surface. The results of the Schirmer-I test, TBUT, and fluorescein-stained corneal surface digital photographs will be assessed at the screening and at week 13. VAS scores will be assessed at the screening, as well as at 1, 3, 5, and 13 weeks. QOL will be evaluated at 1, 3, 5, and 13 weeks.

Discussion

This trial will provide primary data with which to investigate the clinical effectiveness and safety of acupuncture treatment for dry eye syndrome after refractive surgery.

Trial registration

Current Controlled (Identifier: KCT0000727)

Keywords:
Acupuncture; Dry eye; Refractive surgery