Long-term Results of Riboflavin Ultraviolet A Corneal Collagen Cross-linking for Keratoconus in Italy: The Siena Eye Cross Study
Long-term Results of Riboflavin Ultraviolet A Corneal Collagen Cross-linking for Keratoconus in Italy: The Siena Eye Cross Study
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DOI：
10.1016/j.ajo.2009.10.021
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发表时间：
2010-04-01
影响因子：
4.2
通讯作者：
Caporossi, Tomaso
中科院分区：
文献类型：
--
作者：
Caporossi, Aldo;Mazzotta, Cosimo;Caporossi, Tomaso
目的：报告在第一个意大利开放、非随机 II 期临床试验锡耶纳眼交叉研究中，采用联合核黄素紫外线 A 胶原交联治疗的 44 只圆锥角膜的长期结果。设计：透视、非随机、开放试验。方法：经锡耶纳大学机构审查委员会批准，从 2004 年 9 月到 2008 年 9 月，对 363 只患有进行性圆锥角膜的眼睛进行了治疗紫外线与核黄素A胶原交联。手术前后对 44 只眼睛进行了评估，随访时间最短为 48 个月（平均 52.4 个月；范围 48 至 60 个月）。检查包括裸眼视力、最佳眼镜矫正视力、球面眼镜矫正视力、内皮细胞计数（I Konan，Non Con Robo；Konan Medical，Inc.，兵库县，日本）、光学（Visante OCT；Zeiss，耶拿，德国）和超声（DGH；Pachette，Exton，宾夕法尼亚州，美国）测厚、角膜地形图和表面像差测量（CSO Eye Top，佛罗伦萨，意大利）、断层扫描（Orbscan IIz；博士伦公司，罗切斯特，纽约，美国）、后段光学相干断层扫描（Stratus OCT；蔡司，耶拿，德国）和体内共聚焦显微镜（HRT II；海德堡工程公司，罗斯托克，德国）。 结果：经过 48 个月的最低随访后，44 只眼睛检测到圆锥角膜稳定性； 24 个月后，超过 65% 的另一只眼睛显示平均屈光度进展 1.5，然后接受治疗。平均 K 值平均降低 2 屈光度，彗形像差降低且角膜对称性改善超过 85%。平均最佳眼镜矫正视力提高了 1.9 斯内伦线，未矫正视力提高了 2.7 斯内伦线。结论：锡耶纳眼交叉研究的结果显示交联后圆锥角膜具有长期稳定性，无相关副作用。治疗引起的临床、地形和波前改变支持了裸眼视力和最佳眼镜矫正视力的改善。 （美国眼科杂志 2010 年；149：585-593。2010 年，Elsevier Inc. 保留所有权利。）
PURPOSE: To report the long-term results of 44 keratoconic eyes treated by combined riboflavin ultraviolet A collagen cross-linking in the first Italian open, nonrandomized phase II clinical trial, the Siena Eye Cross Study.DESIGN: Perspective, nonrandomized, open trial.METHODS: After Siena University Institutional Review Board approval, from September 2004 through September 2008, 363 eyes with progressive keratoconus were treated with riboflavin ultraviolet A collagen cross-linking. Forty-four eyes with a minimum follow-up of 48 months (mean, 52.4 months; range, 48 to 60 months) were evaluated before and after surgery. Examinations comprised uncorrected visual acuity, best spectacle-corrected visual acuity, spherical spectacle-corrected visual acuity, endothelial cells count (I Konan, Non Con Robo; Konan Medical, Inc., Hyogo, Japan), optical (Visante OCT; Zeiss, Jena, Germany) and ultrasound (DGH; Pachette, Exton, Pennsylvania, USA) pachymetry, corneal topography and surface aberrometry (CSO Eye Top, Florence, Italy), tomography (Orbscan IIz; Bausch & Lomb Inc., Rochester, New York, USA), posterior segment optical coherence tomography (Stratus OCT; Zeiss, Jena, Germany), and in vivo confocal microscopy (HRT II; Heidelberg Engineering, Rostock, Germany).RESULTS: Keratoconus stability was detected in 44 eyes after 48 months of minimum follow-up; fellow eyes showed a mean progression of 1.5 diopters in more than 65% after 24 months, then were treated. The mean K value was reduced by a mean of 2 diopters, and coma aberration reduction with corneal symmetry improvement was observed in more than 85%. The mean best spectacle-corrected visual acuity improved by 1.9 Snellen lines, and the uncorrected visual acuity improved by 2.7 Snellen lines.CONCLUSIONS: The results of the Siena Eye Cross Study showed a long-term stability of keratoconus after cross-linking without relevant side effects. The uncorrected visual acuity and best spectacle-corrected visual acuity improvements were supported by clinical, topographic, and wavefront modifications induced by the treatment. (Am J Ophthalmol 2010;149:585-593. 2010 by Elsevier Inc. All rights reserved.)