Vision Engineering Italy srl, Rome, Italy; Studio Italiano di Oftalmologia, Rome, Italy.
Studio Italiano di Oftalmologia, Rome, Italy.
J Cataract Refract Surg. 2019 Jul;45(7):992-1000. doi: 10.1016/j.jcrs.2019.01.026. Epub 2019 Apr 16.
To evaluate the 2-year clinical outcomes of corneal crosslinking (CXL) using transepithelial iontophoresis CXL (T-ionto CXL) in comparison with standard CXL for the treatment of progressive keratoconus.
Single-site study.
Randomized controlled clinical trial with identifier code NCT02117999.
The eyes of the participants were randomized to have either T-ionto CXL and/or standard CXL. Assessments of uncorrected (UDVA) and corrected (CDVA) distance visual acuities (logarithm of the minimum angle of resolution [logMAR]), manifest refraction spherical equivalent, maximum simulated keratometry (K) (diopters [D]), corneal higher-order aberrations (HOAs), central corneal thickness (CCT), and endothelial cell density (ECD) were performed at 3 days, 7 days, and 1, 3, 6, 12, and 24 months postoperatively.
The study comprised 34 eyes (25 patients). There were 22 eyes in the T-ionto CXL group and 12 eyes in the standard CXL group. Two years after T-ionto CXL and standard CXL, the mean maximum K flattened by -1.05 ± 1.20 D (P = .07) (20 eyes) and -1.51 ± .89 D (P < .001) (11 eyes), respectively. Two study cases (10%) and no control showed maximum K steepening of more than 1.0 D at 24 months postoperatively. The mean change in CDVA was -0.08 ± 0.15 logMAR (P = .04) and -0.02 ± 0.06 logMAR (P = .34) after T-ionto CXL and standard CXL, respectively. A significant average decrease in the myopic defocus (+0.81 D; P < .05) was found in both groups. No significant differences in the outcome measures between treatments were found at 24 months. The corneal HOAs, CCT, and ECD values did not change significantly in any group at 2 years postoperatively.
Clinically significant topographic, visual, and refractive improvements were found 2 years after T-ionto CXL; standard CXL showed more significant corneal apex flattening than the transepithelial iontophoresis protocol.
评估经上皮离子导入角膜交联（T-ionto CXL）与标准 CXL 治疗进行性圆锥角膜的 2 年临床疗效。
单站点研究。
随机对照临床试验，标识符代码为 NCT02117999。
将参与者的眼睛随机分为 T-ionto CXL 和/或标准 CXL 组。在术后 3 天、7 天以及 1、3、6、12 和 24 个月时，分别对未矫正（UDVA）和矫正（CDVA）距离视力（最小角分辨率的对数[logMAR]）、角膜屈光度（等效球镜）、最大模拟角膜曲率（K）（屈光度[D]）、角膜高阶像差（HOAs）、中央角膜厚度（CCT）和内皮细胞密度（ECD）进行评估。
该研究共纳入 34 只眼（25 例患者）。T-ionto CXL 组 22 只眼，标准 CXL 组 12 只眼。T-ionto CXL 和标准 CXL 治疗 2 年后，最大 K 值平均平坦度分别为-1.05±1.20 D（P=0.07）（20 只眼）和-1.51±0.89 D（P<0.001）（11 只眼）。2 例（10%）研究病例和 1 例对照病例在术后 24 个月时最大 K 值增加超过 1.0 D。T-ionto CXL 和标准 CXL 治疗后，CDVA 的平均变化分别为-0.08±0.15 logMAR（P=0.04）和-0.02±0.06 logMAR（P=0.34）。两组的近视离焦均有显著的平均下降（+0.81 D；P<0.05）。24 个月时，两种治疗方法在各项指标上均无显著差异。术后 2 年，各组角膜高阶像差、CCT 和 ECD 值均无显著变化。
T-ionto CXL 治疗后 2 年可获得显著的临床疗效，包括明显的地形学、视觉和屈光改善；标准 CXL 比经上皮离子导入协议更能显著使角膜顶点变平坦。
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