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VX105自动检眼仪客观验光结果准确性分析

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目的:评估VX105自动检眼仪客观验光结果的准确性.方法:收集2024年1月8日~12日来本院就诊的眼科患者109例,根据是否存在屈光介质异常分为两组(屈光介质正常组和屈光介质异常组),应用天乐VX105多功能自动检眼仪和TOPCON KR-800全自动电脑验光仪对同一患者分别测定非睫状肌麻痹下的屈光度.通过配对样本t检验比较两种设备屈光度的差异,采用Bland-Altman法评价两种设备测量的球镜度数、等效球镜度数和柱镜J0/J45的一致性.结果:共纳入109例(218眼),正常组90例(180眼),屈光介质率异常组19例(38眼).在正常组患者中,VX105自动检眼仪和TOPCON KR-800两种设备测得的球镜度数、等效球镜、柱镜光度数J0/柱镜光度数J45分别为:(-0.24±2.39)D,(-0.19±1.08)D;(-0.76±2.49)D,(-0.71±2.74)D;(-0.011±0.456)D,(-0.039±0.462)D;(0.014±0.492)D,(0.009±0.465)D,四个参数都没有显著性差异;Bland-Altman 95%一致性界限法分析发现,VX105自动检眼仪各参数的偏离值分布在95%可信区间内,两种设备的客观验光数据具有较高的一致性.屈光介质异常组患者,两种设备测量的屈光度存在明显差异,其中:屈光介质异常严重的患者,TOPCON KR-800的测量无法显示数据或者所有数据标记为0,而VX105自动检眼仪会标记为-11.0D高度近视.结论:在无严重屈光介质异常的患者中,VX105自动检眼仪与TOPCON KR-800屈光度测量结果基本一致,VX105屈光度测量数据可以替代TOPCON KR-800数据;屈光介质严重混浊的(Ⅲ级核以上白内障)患者中,VX105会显示-11.0D的高度近视,实际使用中需要注意区别.
Accuracy Analysis of Objective Refraction Results by VX105 Auto Refractometer
Objective:To evaluate the accuracy of objective refraction results by the VX105 auto refractometer in different patients.Methods:Collect the data of 109 patients who visited our hospital from January 8th to 12th,2024.Based on the presence or absence of refractive media abnormalities,the patients were divided into two groups(normal refractive media group and abnormal refractive media group).The TianLe VX105 multifunctional automatic eye examination instrument and TOPCON KR-800 fully automatic computerized refractometer were used to measure the refractive power of the same patient under non-cycloplegic conditions.The differences in refractive power measured by the two devices were compared using a paired-sample t-test.The Bland-Altman method was utilized to evaluate the consistency between the measurements of the two devices for spherical degree,equivalent spherical degree,and cylinder values J0/J45.Results:A total of 109 cases(218 eyes)were included,comprising 90 patients(180 eyes)in the normal group and 19 patients(38 eyes)in the abnormal refractive media group.In the normal group,the spherical power,equivalent sphere,cylindrical power J0,and cylindrical power J45 measured by the VX105 automatic refractometer and TOPCON KR-800 are as follows:spherical power:(-0.24±2.39)D,(-0.19±1.08)D,equivalent sphere:(-0.76±2.49)D,(-0.71±2.74)D,cylindrical power J0:(-0.011±0.456)D,(-0.039±0.462)D,cylindrical power J45:(0.014±0.492)D,(0.009±0.465)D.Bland-Altman 95%limits of agreement analysis found that the deviation values for parameters of the VX105 auto refractometer were distributed within a 95%confidence interval,indicating high consistency of objective refraction data between the two devices.However,in the abnormal refractive media group,significant differences were observed between the VX105 and TOPCON KR-800 devices about the refraction data.Specifically,for patients with severe optical media abnormalities,measurements from the TOPCON KR-800 may not display any data or mark all data as 0.On the other hand,the VX105 automatic refractometer may mark the measurement as-11.0D,indicating high myopia.Conclusion:The objective refraction results of the two devices are highly consistent in patients with normal refractive media,the VX105 auto refractometer can be considered as a substitute for the TOPCON KR-800.However,for patients with severe optical media opacities(cataracts of grade Ⅲ and above),the VX105 may show a measurement of-11.0D for high myopia,and caution should be exercised in practical use to differentiate this result.

VX105 auto refractometerTOPCON KR-800objective refractionrefractive media abnormalities

王乐、林元耀、曾宗圣、张广斌

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厦门大学附属厦门眼科中心白内障专科(福建 厦门 361004)

厦门大学附属厦门眼科中心视光科(福建 厦门 361004)

VX105自动检眼仪 TOPCON KR-800 客观验光 屈光介质异常

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(19)