Mazzotta Cosimo, Ferrise Marco, Gabriele Guido, Gennaro Paolo, Meduri Alessandro
Departmental Ophthalmology Unit and USL Toscana Sud-Est, 53100 Siena, Italy.
Post Graduate Ophthalmology School, Siena University, 53100 Siena, Italy.
J Clin Med. 2021 Mar 23;10(6):1324. doi: 10.3390/jcm10061324.
The purpose of this study was to evaluate the effectiveness and safety of a novel buffered riboflavin solution approved for corneal cross-linking (CXL) in progressive keratoconus and secondary corneal ectasia. Following the in vivo preclinical study performed on New Zealand rabbits comparing the novel 0.25% riboflavin solution (Safecross) containing 1% hydroxypropyl methylcellulose (HPMC) with a 0.1% riboflavin solution containing 0.10% EDTA, accelerated epithelium-off CXL was performed on 10 patients (10 eyes treated, with the contralateral eye used as control) through UV-A at a power setting of 9 mW/cm with a total dose of 5.4 J/cm. Re-epithelialization was evaluated in the postoperative 7 days by fluorescein dye test at biomicroscopy; endothelial cell count and morphology (ECD) were analyzed by specular microscopy at the 1st and 6th month of follow-up and demarcation line depth (DLD) measured by anterior segment optical coherence tomography (AS-OCT) one month after the treatment. We observed complete re-epithelization in all eyes between 72 and 96 h after surgery (88 h on average). ECD and morphology remained unchanged in all eyes. DLD was detected at a mean depth of 362 ± 50 µm, 20% over solutions with equivalent dosage. SafeCross riboflavin solution chemically-boosted corneal cross-linking seems to optimize CXL oxidative reaction by higher superoxide anion release, improving DLD by a factor of 20%, without adverse events for corneal endothelium.
本研究的目的是评估一种新的经批准用于圆锥角膜和继发性角膜扩张症角膜交联（CXL）的缓冲核黄素溶液的有效性和安全性。在对新西兰兔进行体内临床前研究后，将含1%羟丙基甲基纤维素（HPMC）的新型0.25%核黄素溶液（Safecross）与含0.10%乙二胺四乙酸（EDTA）的0.1%核黄素溶液进行比较，对10例患者（10只眼接受治疗，对侧眼作为对照）通过紫外线A进行加速去上皮角膜交联，功率设置为9 mW/cm²，总剂量为5.4 J/cm²。术后7天通过生物显微镜下的荧光素染色试验评估再上皮化；在随访的第1个月和第6个月通过镜面显微镜分析内皮细胞计数和形态（ECD），并在治疗后1个月通过眼前节光学相干断层扫描（AS-OCT）测量分界线深度（DLD）。我们观察到所有眼睛在术后72至96小时（平均88小时）内完全再上皮化。所有眼睛的ECD和形态均保持不变。检测到DLD的平均深度为362±50 µm，比同等剂量的溶液高20%。Safecross核黄素溶液化学增强的角膜交联似乎通过更高的超氧阴离子释放优化了CXL氧化反应，使DLD提高了20%，且对角膜内皮无不良事件。
