目的评估国产三维眼前节分析系统Scansys、Pentacam三维眼前节全景分析仪、频域眼前节光学相干断层扫描仪(CASIA SS-1000)和新型超高频数字超声扫描系统(Arcscan Insight100)测量近视眼有晶状体眼后房型人工晶状体(ICL)植入术后中央拱高的差异及一致性。
方法采用诊断试验研究方法，纳入2019年6—12月于河南省人民医院眼科行ICL V4c植入术的近视患者56例56眼，术后同时应用Scansys、Pentacam、CASIA和Arcsan测量中央拱高。比较4种仪器拱高测量值的差异；4种仪器拱高测量值的相关性采用Pearson相关性分析，一致性比较采用Bland-Altman法分析。
结果Scansys、Pentacam、CASIA和Arcscan拱高测量值分别为(481.8±191.6)、(476.4±190.6)、(619.3±207.5)和(534.0±221.2)μm，总体比较差异有统计学意义( F＝143.301， P<0.001)，其中Scansys和Pentacam拱高测量值明显低于CASIA和Arcscan，Arcscan拱高测量值低于CASIA，差异均有统计学意义(均 P<0.001)。Arcscan-CASIA、Arcscan-Pentacam、Arcscan-Scansys、CASIA-Pentacam、CASIA-Scansys、Pentacam-Scansys拱高测量值均呈强正相关( r＝0.982、0.933、0.931、0.942、0.941、0.989，均 P<0.001)。Scansys、Pentacam、CASIA和Arcscan拱高测量值组内相关系数分别为0.985、0.975、0.998、0.992；CASIA和Arcscan、CASIA和Scansys、CASIA和Pantacam、Arcscan和Scansys、Arcscan和Pantacam拱高测量值差值95%一致性界限分别为－170～0、0～280、0～280、－110～210、－100～220 μm，差值的绝对值最大值超出临床的可接受范围，一致性欠佳；Scansys和Pentacam拱高测量值差值95%一致性界限为－60～50 μm，一致性良好。
结论4种仪器测量近视眼ICL V4c植入术后拱高重复性均良好，其中，Scansys和Pentacam的拱高测量值偏小，两者一致性良好，结果可以互相替代；而CASIA拱高测量值最大，其次为Arcscan，彼此差异较大，测量结果不能相互替代，在临床工作中应结合实际情况综合分析。
ObjectiveTo evaluate the consistency of the Chinese three-dimensional anterior visual field analysis system (Scansys), the anterior segment analyzer (Pentacam), the frequency-domain anterior segment optical coherence tomography system (CASIA SS-1000), and a new ultra-high frequency digital ultrasound scanning system (Arcscan Insight100) to measure central vault after implantable collamer lens (ICL) implantation in myopic eyes with crystalline lenses.
MethodsA diagnostic test study was conducted.Fifty-six myopic patients (56 eyes) who underwent ICL V4c implantation from June to December 2019 were included.Scansys, Pentacam, CASIA and Arcscan were used to measure the central vault after surgery.The vault measurements were compared.Correlations between the measurements of the four instruments were analyzed using Pearson correlation analysis, and consistency comparisons were analyzed using the Bland-Altman method.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Henan Eye Hospital (No.HNEECKY-2021[13]). Written informed consent was obtained from each subject.
ResultsThe central vault measurements by Scansys, Pentacam, CASIA and Arcscan were (481.8±191.6), (476.4±190.6), (619.3±207.5) and (534.0±221.2)μm, respectively, with a statistically significant overall difference ( F=143.301, P<0.001). The vault measurements by Scansys and Pentacam were significantly lower than CASIA and Arcscan, and Arcscan was lower than CASIA, with statistically significant differences (all at P<0.001). There were strong positive correlations in vault measurements between Arcscan and CASIA, Arcscan and Pentacam, Arcscan and Scansys, CASIA and Pentacam, CASIA and Scansys, Pentacam and Scansys ( r=0.982, 0.933, 0.931, 0.942, 0.941, 0.989; all at P<0.001). Intraclass correlation coefficients of vault measurements by Scansys, Pentacam, CASIA and Arcscan were 0.985, 0.975, 0.998, 0.992, respectively.The 95% limits of agreement of vault measurements differences were -170 to 0, 0 to 280, 0 to 280, -110 to 210, -100 to 220 μm, between CASIA and Arcscan, CASIA and Scansys, CASIA and Pentacam, Arcscan and Scansys, Arcscan and Pentacam, respectively, and the maximum absolute value of the difference was beyond the clinically acceptable range, showing poor agreement.The 95% limits of agreement of vault measurement difference was -60 to 50 μm between Scansys and Pentacam, showing a good agreement.
ConclusionsThe repeatability of the vault after ICL V4c implantation in myopic eyes measured by the four instruments is good.Among them, the vault measurements of Scansys and Pentacam are smaller, showing good consistency, and their results could be substituted for each other.The measurement of CASIA is the largest, followed by Arcscan, which have a large difference from each other, and their results can not be substituted for each other, which should be comprehensively analyzed with the actual situation in clinical work.
张波,王浩,庞辰久,等. Scansys、Pentacam、CASIA和Arcscan测量近视眼ICL植入术后拱高比较[J]. 中华实验眼科杂志,2024,42(04)：354-360.
DOI:10.3760/cma.j.cn115989-20221023-00492版权归中华医学会所有。
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张波：酝酿和设计试验、实施研究、采集数据、分析/解释数据、文章撰写；王浩、杜文文、孙早荷、李金、顾宇伟、王树林、范棋：采集数据、分析/解释数据、对文章知识性内容作批评性审阅；庞辰久：酝酿和设计试验、指导试验、分析/解释数据、对文章知识性内容作批评性审阅及定稿
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