Vinciguerra Paolo, Randleman J Bradley, Romano Vito, Legrottaglie Emanuela F, Rosetta Pietro, Camesasca Fabrizio I, Piscopo Raffaele, Azzolini Claudio, Vinciguerra Riccardo
J Refract Surg. 2014 Nov;30(11):746-53. doi: 10.3928/1081597X-20141021-06.
To report initial clinical results of transepithelial corneal collagen cross-linking with iontophoresis (I-CXL).
Twenty eyes of 20 patients diagnosed as having progressive keratoconus who underwent I-CXL were included in this prospective non-randomized clinical study. Corrected distance visual acuity (CDVA), spherical equivalent and cylinder refraction, various corneal topography and Scheimpflug tomography parameters, aberrometry, anterior segment optical coherence tomography, and endothelial cell count were assessed at baseline and at 1, 3, 6, and 12 months postoperatively.
CDVA improved significantly at 3, 6, and 12 months postoperatively (logMAR difference of -0.07 ± 0.01, -0.09 ± 0.03, and -0.12 ± 0.06, respectively; P < .05). Aberrometry remained stable during follow-up and a trend toward improvement was noted. All topographic parameters (including maximum keratometry) were stable during the follow-up, but exhibited a positive non-significant trend toward improvement. Minimum corneal thickness values were stable for up to 12 months postoperatively. None of the patients showed a progression of keratoconus. Endothelial cell counts did not change significantly (P > .05).
Preliminary results up to 1 year postoperatively indicate the efficacy of I-CXL in stabilizing the progression of this degenerative disease combined with significant improvement of CDVA. I-CXL, which spares the corneal epithelium, has the potential to become a valid alternative for halting the progression of keratoconus while reducing postoperative patient pain, risk of infection, and treatment time in select patients; however, the relative efficacy of this technique compared to standard epithelium-off techniques remains to be determined.
报告经上皮离子导入角膜胶原交联术(I-CXL)的初步临床结果。
本前瞻性非随机临床研究纳入了20例被诊断为进行性圆锥角膜的患者的20只眼睛,这些患者接受了I-CXL治疗。在基线时以及术后1、3、6和12个月评估矫正远视力(CDVA)、等效球镜度和柱镜验光、各种角膜地形图和眼前节分析系统参数、像差测量、眼前节光学相干断层扫描以及内皮细胞计数。
术后3、6和12个月时CDVA显著改善(logMAR差值分别为-0.07±0.01、-0.09±0.03和-0.12±0.06;P<.05)。像差测量在随访期间保持稳定,并观察到有改善趋势。所有地形图参数(包括最大角膜曲率)在随访期间均稳定,但呈现出非显著性的正向改善趋势。术后长达12个月角膜最薄处厚度值稳定。没有患者出现圆锥角膜进展。内皮细胞计数没有显著变化(P>.05)。
术后长达1年的初步结果表明,I-CXL在稳定这种退行性疾病进展方面有效,同时显著改善了CDVA。I-CXL不损伤角膜上皮,有可能成为阻止圆锥角膜进展的有效替代方法,同时可减轻部分患者术后疼痛、感染风险并缩短治疗时间;然而,与标准的上皮去除技术相比,该技术的相对疗效仍有待确定。