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Development of K-Schirmer Strip and Evaluation of Clinical Availability KCI 등재

K-쉬르머용지의 개발과 임상적 유용성 평가

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대한시과학회지 (The Korean Journal of Vision Science)
대한시과학회 (The Korean Society Of Vision Science)
초록

목적: 이물감 및 자극감을 줄이기 위해 개발한 쉬르머용지의 신뢰도 및 임상적 유용성을 평가하고자 하 였다. 방법: Whatman 용지(#41)를 길이 41 mm, 너비 5 mm, 삽입되는 부분의 폭 3 mm의 스트립 형태로 만 들고 청색 염료가 포함되도록 제작하여 K-쉬르머용지라 명명하였다. 검사법의 신뢰도, 용액의 양과 흡수된 길이의 상관성은 2-10 ㎕의 용액을 1분간 10회씩 흡수시킨 후 평가하였고, 임상 시험의 경우에는 3회 반복 측정하여 평가하였다. 건성안 감별을 위한 민감도 및 특이도 평가는 TBUT 측정값을 기준으로 하여 ROC curve를 이용하여 평가하였다. K-쉬르머용지와 현재 사용되는 쉬르머용지를 비교·평가하기 위해서 시판되 고 있는 Schirmer tear ®(EagleVision Inc., Menphis, TN, USA)를 이용하여 동일한 조건에서 평가하고 비교하였다. 반복측정에 의한 신뢰도는 급내상관계수로 평가하였고, ROC curve는 통계프로그램 Medcalc version 17.5.5(Medcalc Software, Mariakerke, Belgium)를 사용하여 cut-off 값과 곡선아래면적을 정확 도의 지표로 활용하였으며, 유의수준은 p<0.05로 하였다. 결과: K-쉬르머용지와 쉬르머용지 검사법의 신뢰도는 모두 99.9%로 높았고, 용액의 양과 흡수되는 길이 의 상관성 또한 각각 0.982, 0.981로 매우 높았다. 임상검사에서 K-쉬르머검사 결과는 쉬르머검사보다 작 게 측정되었지만(p=0.03), 반복측정에 의한 신뢰도는 66%로 쉬르머검사의 신뢰도 58%에 비하여 높게 측정 되었고, 자극감은 쉬르머검사에 비해 더 작았다(p=0.02). K-쉬르머검사와 쉬르머검사는 상관성을 보였으며 (r=0.59), K-쉬르머검사와 쉬르머검사의 건성안에 대한 민감도와 특이도는 각각 40.35%, 79.07%는 50.88%, 62.79%로 나타났다. 결론: K-쉬르머용지는 신뢰도가 높고 기존의 쉬르머용지에 비해 자극감을 줄일 수 있어 눈물검사도구로 활용 가능할 것으로 판단된다.

Purpose: The purpose of this study was to develop a Schirmer strip for a decrease of irritative and foreign body sensation and evaluate the reliability and clinical usefulness. Methods: The strip was produced by Whatman paper (#41) with 41 mm in length, 5 mm in with 3 mm of width for insertion area and blue dye was included for easy measuring which is named as K-Schirmer strip. To assess the accuracy of K-Schirmer strip, the strips were evaluated after immersed for 1 minute in a solution of 2-10 ㎕. The experiment was repeated 10 times. Reliability of repeated measurements were evaluated through clinical tests. To evaluated the sensitivity and the specificity of the examinations, TBUT test was used as diagnostic criteria for dry eye, and the sensitivity and specificity were analyzed by the receiver operating characteristic (ROC) curve. In order to compare and evaluate the K-Schirmer strip, Schirmer tear® (EagleVision Inc., Menphis, TN, USA) on the market was used under the same conditions. The reliability of repeated measurements was evaluated with intraclass correlation coefficients, and ROC curve was analyzed by the statistical program Medcalc version 17.5.5 (Medcalc Software, Mariakerke). The cut-off value was confirmed and the area under the curve (AUC) as an indicator of accuracy was used, and the significance level was p<0.05. Results: The reliability of both K-Schirmer strip and Schirmer strip were measured as high as 99.9%, and the correlation coefficient of absorbed distance and amount of solution were 0.981 and 0.982, respectively. In clinical tests, the K-Schirmer test value was shorter than the Schirmer test value (p=0.03); however, reliability of repeated measurements was estimated to be 66%, which is higher than that of Schirmer test of 58%, and the degree of irritation with K-Schirmer strip was lower than that of the Schirmer strip(p=0.02). The K-Schirmer and Schirmer test showed high correlation (r=0.59), and the sensitivities and specificities with the K-Schirmer and the Schirmer test for the dry eyes were 40.35%, 79.07%, and 50.88%, 62.79%, respectively. Conclusion: It is considered that K-Schirmer strip as tear test tool reduces the sense of irritation compared to traditional Schirmer strip.

목차
Ⅰ. 서 론
 Ⅱ. 연구재료(대상) 및 방법
  1. K-쉬르머용지의 개발 및 정확도 분석
  2. K-쉬르머용지의 임상적 유용성 평가
  3. 통계분석
 Ⅲ. 결 과
  1. K-쉬르머용지와 쉬르머용지의 정확도분석(in vitro test)
  2. K-쉬르머용지의 임상적 유용성 평가(in vivo test)
 Ⅳ. 고 찰
 Ⅴ. 결 론
 References
저자
  • Jung-Eun Park(Dept. of Optometry, Graduate School of Public Health, Eulji University, Daejeon, 을지대학교 보건대학원 안경광학과) | 박정은
  • Yeon-Hee Kim(Suwon-Seoul-Sungmo Eye Clinic, 수원서울성모안과병원) | 김연희
  • Myeong-Jin Jeong(Dept. of Environmental Health and Safety, Eulji University, 을지대학교 보건환경안전학과) | 정명진
  • Koon-Ja Lee(Dept. of Optometry, Graduate School of Public Health, Eulji University, Daejeon, 을지대학교 보건대학원 안경광학과) | 이군자