Purpose

Wavefront-guided laser in situ keratomileusis (WFG-LASIK) and small incision lenticule extraction (SMILE) are keratorefractive surgeries that can improve uncorrected visual acuity in myopic patients. Comparison of visual outcomes in myopic patients treated with LASIK and SMILE is needed.

Design

Prospective, randomized contralateral eye-controlled trial.

Methods

We performed a single-center prospective, randomized contralateral eye comparison of WFG-LASIK and SMILE (NCT03067077). Myopic patients with low levels of astigmatism were treated with WFG-LASIK in one eye and SMILE in the fellow eye from March 2017 to March 2021. Treatments were randomized by ocular dominance. WFG-LASIK and SMILE were performed. Postoperative evaluation at 1 day consisted of uncorrected distance visual acuity (UDVA), wavefront aberrometry, and a slit-lamp examination. On subsequent postoperative visits at 1 month, 3 months, 6 months, and 12 months, UDVA, manifest refraction, 5% and 25% low-contrast visual acuity, wavefront aberrometry, and slit-lamp examination were performed. Main outcome measure: The primary outcome measure was UDVA at 12 months.

Results

Eighty-eight eyes of 44 patients with myopia were enrolled in the study. Seventy-four eyes of 37 patients had successful treatments and completed 12 months of follow-up. At postoperative month 12, there were a significantly higher proportion of WFG-LASIK eyes that had ≥20/20 UDVA compared with SMILE eyes (94% vs 83%, P < .05). There was no difference between spherical equivalent between WFG-LASIK eyes and SMILE eyes (−0.17 ± 0.25 vs −0.29 ± 0.38, P > .05); there was no difference in higher order aberrations, including coma, trefoil, and spherical aberrations (P > 0.05); and there were a significantly higher proportion of WFG-LASIK eyes that had improved 5% and 25% low-contrast visual acuity compared with SMILE eyes (P < 0.05).

Conclusions

WFG-LASIK and SMILE both offered marked improvements in corrected distance visual acuity and excellent predictability in both eyes. Compared with SMILE, WFG-LASIK resulted in faster visual recovery, better low-contrast visual acuity, and greater gains in uncorrected visual acuity.

中文翻译：

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波前引导激光原位角膜磨镶术和小切口晶状体摘除屈光手术的前瞻性、随机对侧眼比较

目的

波前引导激光原位角膜磨镶术 (WFG-LASIK) 和小切口微透镜摘除术 (SMILE) 是角膜屈光手术，可以改善近视患者的裸眼视力。需要比较接受 LASIK 和 SMILE 治疗的近视患者的视力结果。

设计

前瞻性随机对侧眼对照试验。

方法

我们对 WFG-LASIK 和 SMILE (NCT03067077) 进行了单中心前瞻性随机对侧眼比较。2017 年 3 月至 2021 年 3 月，低度散光近视患者的一只眼接受了 WFG-LASIK 治疗，另一只眼接受了 SMILE 治疗。治疗按优势眼随机分配。进行了 WFG-LASIK 和 SMILE。术后 1 天的评估包括裸眼远视力 (UDVA)、波前像差测量和裂隙灯检查。在术后 1 个月、3 个月、6 个月和 12 个月的随访中，进行了 UDVA、显性屈光、5% 和 25% 低对比度视力、波前像差测量和裂隙灯检查。主要结果指标：主要结果指标是 12 个月时的 UDVA。

结果

44 名近视患者的 88 只眼睛被纳入研究。37例患者74只眼均获得成功治疗并完成12个月的随访。术后第 12 个月，与 SMILE 眼相比，WFG-LASIK 眼中 UDVA ≥ 20/20 的比例明显更高（94% 对 83%，P < .05）。WFG-LASIK 眼和 SMILE 眼之间的等效球镜没有差异（−0.17 ± 0.25 vs −0.29 ± 0.38，P > .05）；慧差、三叶像差、球差等高阶像差差异无统计学意义（P > 0.05）；与 SMILE 眼相比，WFG-LASIK 眼低对比度视力分别提高 5% 和 25% 的比例明显更高（P < 0.05）。

结论

WFG-LASIK 和 SMILE 均显着改善了矫正远视力和双眼的出色可预测性。与 SMILE 相比，WFG-LASIK 导致更快的视力恢复、更好的低对比度视力和更大的未矫正视力增益。