Abstract：
BACKGROUND: Implantable collamer lens implantation (ICL) is a form of \'foldable\' posterior chamber phakic intraocular lens refractive surgery that generally does not impair cornea and natural accommodation. The potential advantages of the ICL over keratorefractive laser procedures include less induction of higher-order aberrations (HOAs) and enhanced retinal image magnification. On the other hand, small incision lenticule extraction (SMILE), currently, one of the most popular refractive surgery procedures, also offers excellent visual outcomes, particularly for eyes with low to moderate amounts of myopia. The aim of this study is to evaluate whether ICL/TICL (toric ICL) is comparable to SMILE for low to moderate myopia in terms of refractive outcomes at 3 and 18 months post-operatively.
METHODS: This is a prospective randomized study. A total of 300 participants will be randomized into two groups, the ICL/TICL group and SMILE group. Eligible participants with spherical equivalent (SE) less than - 6.0 diopter (D) will be recruited. Following randomization, participants will be followed at 1, 3, 6, 12, and 18 months. The primary outcome is the refractive predictability at every postoperative point after surgery, which is the proportion of the number of eyes achieving a postoperative SE within ± 0.5 D and ± 1.0 D of the intended target. Secondary outcome parameters include visual acuity, refraction, adverse events, and quality of vision measurements.
CONCLUSIONS: This trial will provide information on whether ICL has comparable, if not superior, refractive outcomes compared to the established SMILE for low to moderate myopia, thus providing evidence for translation into clinical practice.
BACKGROUND: Chinese clinical trial registry (ChiCTR) 2200055372. Registered on 08 January 2022.
METHODS: This is a prospective randomized study. A total of 300 participants will be randomized into two groups, the ICL/TICL group and SMILE group. Eligible participants with spherical equivalent (SE) less than - 6.0 diopter (D) will be recruited. Following randomization, participants will be followed at 1, 3, 6, 12, and 18 months. The primary outcome is the refractive predictability at every postoperative point after surgery, which is the proportion of the number of eyes achieving a postoperative SE within ± 0.5 D and ± 1.0 D of the intended target. Secondary outcome parameters include visual acuity, refraction, adverse events, and quality of vision measurements.
CONCLUSIONS: This trial will provide information on whether ICL has comparable, if not superior, refractive outcomes compared to the established SMILE for low to moderate myopia, thus providing evidence for translation into clinical practice.
BACKGROUND: Chinese clinical trial registry (ChiCTR) 2200055372. Registered on 08 January 2022.
摘要：
背景：植入式晶状体植入术（ICL）是一种可折叠的后房型晶状体屈光手术，通常不会损害角膜和自然调节。ICL优于角膜折光激光手术的潜在优势包括较少诱导高阶像差（HOA）和增强的视网膜图像放大倍数。另一方面,小切口微透镜提取(SMILE)，目前,最受欢迎的屈光手术之一,还提供了出色的视觉效果，特别是对于低到中度近视的眼睛。这项研究的目的是评估ICL/TICL（复曲面ICL）是否与SMILE在术后3和18个月的屈光结果方面具有可比性。
方法：这是一项前瞻性随机研究。共有300名参与者将被随机分为两组，ICL/TICL组和SMILE组。将招募球面当量(SE)小于-6.0屈光度(D)的合格参与者。随机化后，参与者将在1,3,6,12和18个月时接受随访.主要结果是手术后每个术后点的屈光可预测性，这是在预期目标的±0.5D和±1.0D内达到术后SE的眼睛数量的比例。次要结果参数包括视力，折射,不良事件,和视觉测量的质量。
结论：本试验将提供有关ICL是否具有可比性的信息，如果不是优越的，屈光结果与既定的SMILE对低至中度近视的比较，从而为转化为临床实践提供证据。
背景：中国临床试验注册（ChiCTR）2200055372。2022年1月8日注册
方法：这是一项前瞻性随机研究。共有300名参与者将被随机分为两组，ICL/TICL组和SMILE组。将招募球面当量(SE)小于-6.0屈光度(D)的合格参与者。随机化后，参与者将在1,3,6,12和18个月时接受随访.主要结果是手术后每个术后点的屈光可预测性，这是在预期目标的±0.5D和±1.0D内达到术后SE的眼睛数量的比例。次要结果参数包括视力，折射,不良事件,和视觉测量的质量。
结论：本试验将提供有关ICL是否具有可比性的信息，如果不是优越的，屈光结果与既定的SMILE对低至中度近视的比较，从而为转化为临床实践提供证据。
背景：中国临床试验注册（ChiCTR）2200055372。2022年1月8日注册
