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Evaluation of the validity and reliability of A-scan ultrasound biometry with a single use disposable cover

机译:一次性使用一次性覆盖物评估A扫描超声生物测定法的有效性和可靠性

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摘要

Background: The UK Medical Devices Agency has suggested that ophthalmic practitioners should, where practicable and not compromising clinical outcome, restrict corneal contact devices to single patient use to minimise a remote theoretical risk of transmission of new variant Creutzfeldt-Jakob disease (vCJD). This study reports on a modified technique of ultrasound A-scan biometry that complies with the MDA recommendations.Methods: The right eyes of 37 consecutive hospital patients had a series of biometry readings taken with a Humphrey 820 A-scan instrument with a plane wave transducer use d conventionally and with the addition of a disposable latex cover.Results: Intrasessional repeatability of axial length measurements was similar for conventional readings—mean difference 0.027 mm, 95% confidence intervals (CI) ± 0.44 mm and those taken with a disposable cover (0.028 mm, CI ± 0.38). Intersessional repeatability was equivalent with (0.002 mm, CI ± 0.51) and without a cover (0.03 mm, CI ± 0.51). Readings with a cover were not significantly different from those without (paired t test; p >0.05), but tended to be greater (mean difference 0.085 mm, CI ± 0.60).Conclusions: These findings suggest that corneal contact biometry with a disposable cover is a viable and theoretically safer alternative to the conventional technique.
机译:背景:英国医疗器械局(UK Medical Devices Agency)建议,在可行且不影响临床效果的情况下,眼科医师应将角膜接触器械限制在单人使用,以最大程度地减少新的克雅氏病(vCJD)传播的远距离理论风险。这项研究报告了一种符合MDA建议的改进的超声A扫描生物测定技术。方法:连续37例住院患者的右眼使用带有平面波换能器的Humphrey 820 A扫描仪进行一系列生物测定读数结果:常规读数时的术中轴向长度测量的重复性与常规读数相似,均差为0.027 mm,95%置信区间(CI)±0.44 mm,而采用一次性覆盖物( 0.028毫米,CI±0.38)。闭会期间重复性等效于(0.002 mm,CI±0.51),无覆盖物(0.03 mm,CI±0.51)。有覆盖物的读数与没有覆盖物的读数无显着差异(配对t检验; p> 0.05),但有更大的趋势(平均差异0.085 mm,CI±0.60)。结论:这些发现表明,使用一次性覆盖物进行角膜接触生物测定是传统技术的可行且理论上更安全的替代方法。

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