Ng Alex L K, Chan Tommy C Y, Cheng George P M, Jhanji Vishal, Ye Cong, Woo Victor C P, Lai Jimmy S M
Department of Ophthalmology, LKS Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.
Department of Ophthalmology, LKS Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong; Department of Ophthalmology, Hong Kong Eye Hospital, Kowloon, Hong Kong; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Kowloon, Hong Kong.
J Ophthalmol. 2016;2016:2672980. doi: 10.1155/2016/2672980. Epub 2016 Apr 27.
Background. To compare the early outcome of combined SMILE and collagen crosslinking (SMILE Xtra) with SMILE. Method. Prospective, comparative interventional study of 21 eyes receiving SMILE Xtra using a low energy protocol and 32 control eyes receiving SMILE only. The outcomes were compared at 1, 3, and 6 months postoperatively. Results. Both groups had myopia with spherical equivalent refraction (SEQ) > 4.00 D. The SMILE Xtra group had thinner preoperative central corneal thickness and residual stromal bed thickness (p < 0.021). At 6 months, no eyes lost more than 1 line in corrected distance visual acuity. The safety index was 0.96 ± 0.06 and 1.00 ± 0.00 in SMILE Xtra and control, respectively (p < 0.001). 89% and 94% of eyes were within ±0.50 D of target refraction, respectively, with the mean error in SEQ correction being -0.17 ± 0.26 D for SMILE Xtra and +0.03 ± 0.25 D for control (p = 0.021). The efficacy index was 0.88 ± 0.13 and 0.97 ± 0.06, respectively (p = 0.005). Conclusion. SMILE Xtra had good overall safety profile and predictability at 6 months. However, when compared with control, the safety index and efficacy index were statistically significantly lower in the early postoperative period.
背景。比较联合小切口基质透镜切除术（SMILE）和胶原交联术（SMILE Xtra）与单纯SMILE的早期效果。方法。对21只接受低能量方案的SMILE Xtra手术的眼睛和32只仅接受SMILE手术的对照眼睛进行前瞻性、对比性干预研究。在术后1、3和6个月比较结果。结果。两组均为等效球镜度数（SEQ）>4.00 D的近视患者。SMILE Xtra组术前中央角膜厚度和残余基质床厚度更薄（p<0.021）。在6个月时，矫正远视力下降超过1行的眼睛为零。SMILE Xtra组和对照组的安全指数分别为0.96±0.06和1.00±0.00（p<0.001）。分别有89%和94%的眼睛屈光度数在目标值±0.50 D范围内，SMILE Xtra组SEQ矫正的平均误差为-0.17±0.26 D，对照组为+0.03±0.25 D（p=0.021）。疗效指数分别为0.88±0.13和0.97±0.06（p=0.005）。结论。SMILE Xtra在6个月时具有良好的总体安全性和可预测性。然而，与对照组相比，术后早期的安全指数和疗效指数在统计学上显著更低。
