一项前瞻性、比较性临床研究，旨在评估两种不同的0.1%核黄素溶液用于圆锥角膜患者胶原交联治疗的安全性和有效性。

A Prospective, Comparative, Clinical Study to Evaluate the Safety and Efficacy of Two Different 0.1% Riboflavin Solutions Used in Collagen Crosslinking Treatment for Patients with Keratoconus.

作者信息

Brar Sheetal, Ganesh Sri, Reddy Shilpa S, Bn Nagesh, Shahanand Dhwni

机构信息

Department of Phaco-Refractive Surgery, Nethradhama Superspecialty Eye Hospital, Bangalore, Karnataka, India.

出版信息

Clin Ophthalmol. 2021 Jun 21;15:2607-2617. doi: 10.2147/OPTH.S313647. eCollection 2021.

DOI:10.2147/OPTH.S313647

PMID:34188439

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8232965/

Abstract

PURPOSE

To compare the safety and efficacy of 0.1% riboflavin in two different solutions which is used in corneal collagen crosslinking (CXL) for the treatment of keratoconus.

METHODS

This was a prospective, randomized, comparison study which included 100 eyes of 61 patients with progressive keratoconus who underwent CXL with riboflavin 0.1% solution as a photosensitizer, using the standard Dresden protocol of using 3mW/cm UV-A irradiation for 30 minutes which corresponds to a total energy of 5.4 J/cm. The recruited patients were divided into 2 groups ie, Flavin Group and Peschke-D group by computer generated randomization. Postoperative examinations were conducted on 1 day, 1 month, 3 months, 6 months and 12 months after the crosslinking.

RESULTS

For both groups, the mean manifest spherical equivalent (SE), astigmatism, best corrected distance visual acuity, keratometry values, thinnest pachymetry values, demarcation line depth and endothelial cell density preoperatively and at postoperative 12 months were comparable with no statistically significant differences. At 12 months postoperatively, 62% of eyes in the Flavin group, and 68% of eyes in the Peschke-D group had postoperative manifest SE of within ± 1.00 D. During UV-A exposure, the cornea in the Flavin group showed intraoperative thinning of 112 microns (27%) as compared with a thinning of 108.12 microns (26.5%) observed in the Peschke group (p=1.67) from the initial pachymetry readings. No eye in either group had any immediate or long-term postop vision threatening complications such as infectious keratitis, corneal melt, non-resolving corneal oedema or endothelial decompensation.

CONCLUSION

Both riboflavin solutions were equally safe and effective in the management of progressive keratoconus, and resulted in similar changes in terms of mean manifest spherical equivalent (SE), astigmatism, best corrected distance visual acuity, keratometry values, thinnest pachymetry values, demarcation line depth and endothelial cell density at the end of 12 months postoperatively.

TRIAL REGISTRATION NUMBER

Ctri/2019/11/021841 (Www.ctri.nic.in).

摘要

目的

比较用于角膜胶原交联（CXL）治疗圆锥角膜的两种不同溶液中0.1%核黄素的安全性和有效性。

方法

这是一项前瞻性、随机对照研究，纳入了61例进行性圆锥角膜患者的100只眼，这些患者使用0.1%核黄素溶液作为光敏剂进行CXL，采用德累斯顿标准方案，即使用3mW/cm的UV-A照射30分钟，总能量为5.4J/cm²。通过计算机随机分组，将招募的患者分为两组，即黄素组和佩施克-D组。交联术后1天、1个月、3个月、6个月和12个月进行术后检查。

结果

两组患者术前及术后12个月的平均明显球镜等效度（SE）、散光、最佳矫正远视力、角膜曲率计值、最薄角膜厚度值、分界线深度和内皮细胞密度均具有可比性，无统计学显著差异。术后12个月时，黄素组62%的眼和佩施克-D组68%的眼术后明显SE在±1.00D以内。在UV-A照射期间，黄素组角膜术中变薄112微米（27%），而佩施克组从初始角膜厚度读数观察到变薄108.12微米（26.5%）（p=1.67）。两组均无眼发生任何即刻或长期的威胁术后视力的并发症，如感染性角膜炎、角膜溶解、无法消退的角膜水肿或内皮失代偿。