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三种不同交联方案治疗儿童圆锥角膜的疗效分析:一项多中心随机对照试验

Analysis of the outcomes of three different cross-linking protocols for treatment of paediatric keratoconus: A multicentre randomized controlled trial.

作者信息

Iqbal Mohammed, Gad Ahmed, Kotb Ahmed, Abdelhalim Mahmoud

机构信息

Department of Ophthalmology, Faculty of Medicine, Sohag University, Sohag, Egypt.

Department of Ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.

出版信息

Acta Ophthalmol. 2024 Feb;102(1):e105-e116. doi: 10.1111/aos.15686. Epub 2023 May 4.

Abstract

PURPOSE

To analyse long-term outcomes of standard cross-linking (SCXL), accelerated cross-linking (ACXL) and transepithelial cross-linking (TCXL) in the treatment of progressive paediatric keratoconus regarding stability, safety and efficacy.

METHODS

This prospective multicentre randomized controlled trial included 97 eyes of 97 paediatric patients with stages I-III ABCD keratoconus grading system, who were randomized into three groups; SCXL group (control group, n = 32; 3 mW/cm  × 30 min/5.4 J/cm ), ACXL (n = 33; 18 mW/cm  × 5 min/5.4 J/cm ) and TCXL (n = 32; 18 mW/cm  × 5 min/5.4 J/cm ). Subjective refraction, uncorrected and corrected visual acuity, keratometry and pachymetry measurements using corneal topography were recorded preoperatively and 1, 2 and 3 years postoperatively.

RESULTS

SCXL group exhibited significant successive improvements in the mean visual, refractive and keratometric parameters throughout the entire postoperative 3 years while ACXL group exhibited significant improvements in visual and keratometric parameters in the first postoperative year that remained stable in second and third postoperative years. TCXL group exhibited significant progressive deterioration in all mean parameters compared to SCXL and ACXL (p < 0.0001). Both SCXL and ACXL revealed final 100% success rate with good stability while TCXL revealed final 22% failure rate with keratoconus progression (p < 0.0001).

CONCLUSION

SCXL and ACXL were comparable in halting keratoconus progression and achieved good stability and safety; however, SCXL was more efficient than ACXL as it yielded greater significant postoperative mean visual, refractive and keratometric improvements achieving smoother corneal remodelling. Both SCXL and ACXL were much superior to TCXL. SCXL is the best CXL treatment option for paediatric keratoconus while ACXL is a good and effective alternative.

摘要

目的

分析标准交联(SCXL)、加速交联(ACXL)和经上皮交联(TCXL)治疗进展性儿童圆锥角膜在稳定性、安全性和有效性方面的长期效果。

方法

这项前瞻性多中心随机对照试验纳入了97例患有I-III期ABCD圆锥角膜分级系统的儿童患者的97只眼,这些患者被随机分为三组;SCXL组(对照组,n = 32;3 mW/cm×30 min/5.4 J/cm),ACXL组(n = 33;18 mW/cm×5 min/5.4 J/cm)和TCXL组(n = 32;18 mW/cm×5 min/5.4 J/cm)。术前以及术后1年、2年和3年记录主观验光、未矫正和矫正视力、角膜曲率测量以及使用角膜地形图进行的角膜厚度测量。

结果

SCXL组在术后整个3年期间,平均视力、屈光和角膜曲率参数均有显著的持续改善,而ACXL组在术后第一年视力和角膜曲率参数有显著改善,在术后第二年和第三年保持稳定。与SCXL组和ACXL组相比,TCXL组所有平均参数均呈现显著的进行性恶化(p < 0.0001)。SCXL组和ACXL组最终成功率均为100%,稳定性良好,而TCXL组最终失败率为22%,伴有圆锥角膜进展(p < 0.0001)。

结论

SCXL和ACXL在阻止圆锥角膜进展方面具有可比性,并且具有良好的稳定性和安全性;然而,SCXL比ACXL更有效,因为它在术后平均视力、屈光和角膜曲率方面有更大的显著改善,实现了更平滑的角膜重塑。SCXL和ACXL均明显优于TCXL。SCXL是儿童圆锥角膜最佳的交联治疗选择,而ACXL是一种良好且有效的替代方案。

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