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与标准交联相比,离子电渗胶原交联治疗早期进行性圆锥角膜的评估:一项非劣效性研究。

Evaluation of Iontophoretic Collagen Cross-linking for Early Stage of Progressive Keratoconus Compared to Standard Cross-linking: A Non-Inferiority Study.

作者信息

Cantemir Alina, Alexa Anisia I, Anton Nicoleta, Ciuntu Roxana E, Danielescu Ciprian, Chiselita Dorin, Costin Danut

机构信息

"Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania.

出版信息

Ophthalmol Ther. 2017 Jun;6(1):147-160. doi: 10.1007/s40123-017-0076-8. Epub 2017 Feb 3.

Abstract

INTRODUCTION

The purpose of this study was to evaluate the efficacy and safety of iontophoretic collagen cross-linking (I-CXL) compared to epithelium-off standard collagen cross-linking (CXL) in treating the early stages of progressive keratoconus.

METHODS

This retrospective cohort study at Oftaprof Clinic, Iasi, Romania included 40 eyes of 40 patients with progressive keratoconus stage I according to the Amsler classification who underwent I-CXL and the results were compared with a matched group of 40 eyes from 40 patients who received standard CXL. The follow-up period was 24 months. Uncorrected (UCVA) and corrected (CDVA) distance visual acuities, corneal topography, and pachymetry were evaluated in all patients.

RESULTS

The mean patient age was 26.52 ± 3.77 years for the standard CXL group and 28.32 ± 4.91 for the I-CXL group. The mean UCVA and CDVA improved significantly in both groups. At 12 months, the improvement of UCVA was greater in the I-CXL group (P < 0.05). There was a statistically significant different trend in CDVA between groups with a more favorable outcome for the standard CXL group (P < 0.01). The manifest cylinder decreased by a mean of 0.962 ± 0.114 D in the epithelium-off CXL group and by 0.831 ± 0.082 D in the I-CXL group (P < 0.001). At 24 months, the K values improved by 1.2 ± 0.199 D in the standard group and by 0.908 ± 0.177 D in the I-CXL group (P < 0.001).

CONCLUSION

All parameters either improved or remained unchanged after the iontophoretic collagen cross-linking intervention. I-CXL was found to be as effective as the standard technique.

摘要

引言

本研究旨在评估离子导入胶原交联术(I-CXL)与去上皮标准胶原交联术(CXL)相比,在治疗早期进行性圆锥角膜中的疗效和安全性。

方法

在罗马尼亚雅西的奥夫塔罗夫诊所进行的这项回顾性队列研究,纳入了40例根据阿姆斯勒分类法处于I期进行性圆锥角膜的患者的40只眼,这些患者接受了I-CXL,并将结果与40例接受标准CXL的患者的40只眼的匹配组进行比较。随访期为24个月。对所有患者评估未矫正(UCVA)和矫正(CDVA)远视力、角膜地形图和角膜厚度测量。

结果

标准CXL组患者的平均年龄为26.52±3.77岁,I-CXL组为28.32±4.91岁。两组的平均UCVA和CDVA均显著改善。在12个月时,I-CXL组的UCVA改善更大(P<0.05)。两组之间CDVA存在统计学上的显著差异趋势,标准CXL组的结果更有利(P<0.01)。去上皮CXL组的明显柱镜度数平均降低0.962±0.114D,I-CXL组降低0.831±0.082D(P<0.001)。在24个月时,标准组的K值改善了1.2±0.199D,I-CXL组改善了0.908±0.177D(P<0.001)。

结论

离子导入胶原交联干预后,所有参数均有所改善或保持不变。发现I-CXL与标准技术一样有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dbc1/5449295/d4e360c7263a/40123_2017_76_Fig2_HTML.jpg

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