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有或无上皮清创的离子导入角膜交联术与标准角膜交联术的比较:一项前瞻性临床研究的2年临床结果

Iontophoresis CXL With and Without Epithelial Debridement Versus Standard CXL: 2-Year Clinical Results of a Prospective Clinical Study.

作者信息

Vinciguerra Paolo, Rosetta Pietro, Legrottaglie Emanuela F, Morenghi Emanuela, Mazzotta Cosimo, Kaye Stephen B, Vinciguerra Riccardo

出版信息

J Refract Surg. 2019 Mar 1;35(3):184-190. doi: 10.3928/1081597X-20190128-01.

Abstract

PURPOSE

To compare the 2-year follow-up outcomes of three groups of patients with keratoconus treated with transepithelial iontophoresis (I-CXL), iontophoresis with epithelial removal (I-SCXL), and standard epithelium-off (S-CXL) CXL for progressive keratoconus.

METHODS

Sixty eyes of 60 patients treated with CXL for progressive keratoconus were included in this comparative, prospective clinical study. Twenty patients were included in each group (I-CXL, I-SCXL, and S-CXL). Corrected distance visual acuity (CDVA), refraction, corneal topography, Scheimpflug tomography, and aberrometry were assessed at baseline and at 1, 3, 6, 12, and 24 months of follow-up. To assess the long-term safety and efficacy of these treatments, the preoperative values were compared with the values at 24 months of follow-up.

RESULTS

The main outcome of the study was the non-statistically significant difference between the three protocols in induced change in most of the parameters, including visual acuity (P = .665), topographic indexes (all P > .05), and maximum keratometry (P = .611) after 2 years of follow-up. There were no significant differences in the change in refractive error following CXL in all groups or between groups (all P > .05). Conversely, I-CXL induced significantly less corneal thinning (P = .0299 and .0121) and a significantly greater reduction of higher order aberrations and coma (all P < .0001) compared to S-CXL and I-SCXL. All protocols induced a significant increase in visual acuity (S-CXL P = .0004, I-SCXL P = .0045, and I-CXL P = .004).

CONCLUSIONS

The 2-year results of this comparative, prospective clinical study demonstrate the efficacy and safety of I-CXL to treat progressive keratoconus and overcome the limitations of CXL with epithelial debridement. [J Refract Surg. 2019;35(3):184-190.].

摘要

目的

比较经上皮离子导入角膜交联术(I-CXL)、上皮去除离子导入角膜交联术(I-SCXL)和标准去上皮角膜交联术(S-CXL)治疗圆锥角膜的三组患者的2年随访结果。

方法

本比较性前瞻性临床研究纳入了60例因圆锥角膜接受角膜交联术治疗的患者的60只眼。每组纳入20例患者(I-CXL组、I-SCXL组和S-CXL组)。在基线以及随访的1、3、6、12和24个月时评估矫正远视力(CDVA)、屈光、角膜地形图、眼前节光学相干断层扫描和像差测量。为评估这些治疗方法的长期安全性和有效性,将术前值与24个月随访时的值进行比较。

结果

该研究的主要结果是,在随访2年后,三种方案在大多数参数的诱导变化方面无统计学显著差异,包括视力(P = 0.665)、地形学指数(所有P > 0.05)和最大角膜曲率(P = 0.611)。所有组或组间角膜交联术后屈光不正的变化均无显著差异(所有P > 0.05)。相反,与S-CXL和I-SCXL相比,I-CXL导致的角膜变薄明显更少(P = 0.0299和0.0121),高阶像差和彗差的降低明显更大(所有P < 0.0001)。所有方案均使视力显著提高(S-CXL组P = 0.0004,I-SCXL组P = 0.0045,I-CXL组P = 0.004)。

结论

这项比较性前瞻性临床研究的2年结果证明了I-CXL治疗进行性圆锥角膜的有效性和安全性,并克服了去上皮角膜交联术的局限性。[《屈光手术杂志》。2019;35(3):184 - 190。]

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