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波前引导准分子原位角膜磨镶术与小切口基质透镜切除术屈光手术的前瞻性、随机对侧眼比较

Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries.

作者信息

Chiang Bryce, Valerio Gabriel S, Manche Edward E

机构信息

From the Department of Ophthalmology, Byers Eye Institute at Stanford, Stanford University, Palo Alto, California, USA.

From the Department of Ophthalmology, Byers Eye Institute at Stanford, Stanford University, Palo Alto, California, USA..

出版信息

Am J Ophthalmol. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14.

DOI:10.1016/j.ajo.2021.11.013
PMID:34788593
Abstract

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.

摘要

目的

波前引导准分子原位角膜磨镶术(WFG-LASIK)和小切口基质透镜切除术(SMILE)是可以提高近视患者裸眼视力的角膜屈光手术。需要比较接受LASIK和SMILE治疗的近视患者的视觉效果。

设计

前瞻性、随机对侧眼对照试验。

方法

我们进行了一项单中心前瞻性、随机对侧眼比较WFG-LASIK和SMILE的研究(NCT03067077)。2017年3月至2021年3月,散光程度较低的近视患者一只眼接受WFG-LASIK治疗,另一只眼接受SMILE治疗。治疗根据优势眼随机分配。实施WFG-LASIK和SMILE手术。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个月的后续随访中,进行UDVA、显然验光、5%和25%低对比度视力、波前像差测量和裂隙灯检查。

主要观察指标

主要观察指标是术后12个月的UDVA。

结果

44例近视患者的88只眼纳入研究。37例患者的74只眼治疗成功并完成了12个月的随访。术后12个月时,与SMILE组眼相比,WFG-LASIK组眼中UDVA≥20/20的比例显著更高(94%对83%,P<.05)。WFG-LASIK组眼和SMILE组眼的等效球镜度之间无差异(-0.17±0.25对-0.29±0.38,P>.05);包括彗差、三叶草像差和球差在内的高阶像差无差异(P>0.05);与SMILE组眼相比,WFG-LASIK组眼中5%和25%低对比度视力改善的比例显著更高(P<.05)。

结论

WFG-LASIK和SMILE在矫正远视力方面均有显著改善,且两眼的预测性均良好。与SMILE相比,WFG-LASIK导致视力恢复更快、低对比度视力更好以及裸眼视力提高幅度更大。

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