소아근시에 대한 눈 주위혈 지압의 유효성 및 안전성 평가 연구
The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children: A Study Protocol
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Objectives Myopia has a higher prevalence rate in eastern countries, which also have a higher rate of educational fever compared to western countries. Considering this, social costs paid for myopia will increase rapidly in Korea. Although the development of myopia treatment is necessary, there has been a lack of relevant studies. Thus, this study aims to produce data to prevent unnecessary treatments and medical expenses. Methods The objective is to evaluate the effect of periocular acupressure exerted by a medical massager for myopia. This is an open-label, prospective, single-arm, and pre and post superiority study. The subjects are 7~12-year-old myopia patients with under 5 D (diopter) of spherical equivalent. A total of 56 subjects were enrolled. The selected subjects will wear the massager for 15 minutes twice a day for 24 weeks. The primary endpoint is the refraction change. The secondary endpoint is the axial length change. Statistical analysis was performed at a significant level of 0.05, using a two-tailed test. The criterion for significantly improved refraction was -0.17±0.50 D/6 months and that of axial length change was 0.126 mm. Results and Conclusions This study did not include a control group because children represent a vulnerable group. This objective study will bring some impact on Korean medical myopia treatment. A long-term confirmatory clinical study may be necessary in future.
Abstract
Objectives Myopia has a higher prevalence rate in eastern countries, which also have a higher rate of educational fever compared to western countries. Considering this, social costs paid for myopia will increase rapidly in Korea. Although the development of myopia treatment is necessary, there has been a lack of relevant studies. Thus, this study aims to produce data to prevent unnecessary treatments and medical expenses. Methods The objective is to evaluate the effect of periocular acupressure exerted by a medical massager for myopia. This is an open-label, prospective, single-arm, and pre and post superiority study. The subjects are 7~12-year-old myopia patients with under 5 D (diopter) of spherical equivalent. A total of 56 subjects were enrolled. The selected subjects will wear the massager for 15 minutes twice a day for 24 weeks. The primary endpoint is the refraction change. The secondary endpoint is the axial length change. Statistical analysis was performed at a significant level of 0.05, using a two-tailed test. The criterion for significantly improved refraction was -0.17±0.50 D/6 months and that of axial length change was 0.126 mm. Results and Conclusions This study did not include a control group because children represent a vulnerable group. This objective study will bring some impact on Korean medical myopia treatment. A long-term confirmatory clinical study may be necessary in future.
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