The AIER School of Ophthalmology of Central, South University, Hunan Province, Changsha, China.
The AIER Eye and Refractive Institute of Central, South University, Hunan Province, Changsha, China.
Trials. 2022 Oct 28;23(1):910. doi: 10.1186/s13063-022-06851-3.
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/DESIGN: 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.
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.
Chinese clinical trial registry (ChiCTR) 2200055372. Registered on 08 January 2022.
可折叠后房房角固定型人工晶状体植入术（ICL）是一种“折叠式”后房有晶状体眼屈光性白内障手术，通常不会损害角膜和自然调节。与角膜屈光性激光手术相比，ICL 的潜在优势包括诱导高阶像差（HOAs）的可能性较小，以及视网膜图像放大增强。另一方面，小切口微透镜提取术（SMILE）目前是最受欢迎的屈光手术之一，也能提供出色的视觉效果，尤其对中低度近视的眼睛效果更好。本研究旨在评估在术后 3 个月和 18 个月时，对于低中度近视患者，ICL/TICL（矫正型 ICL）的屈光效果是否与 SMILE 相当。
方法/设计：这是一项前瞻性随机研究。总计 300 名参与者将被随机分为 ICL/TICL 组和 SMILE 组。纳入等效球镜（SE）小于-6.0 屈光度（D）的合格参与者。随机分组后，参与者将在术后 1、3、6、12 和 18 个月进行随访。主要结局是术后每个随访点的屈光预测性，即术后 SE 达到预期目标的±0.5 D 和±1.0 D 范围内的眼数比例。次要结局参数包括视力、屈光度、不良事件和视觉质量测量。
本试验将提供有关 ICL 是否具有与 SMILE 相当（如果不是更好）的屈光效果的信息，适用于低中度近视患者，从而为其转化为临床实践提供依据。
中国临床试验注册中心（ChiCTR）2200055372. 注册于 2022 年 1 月 8 日。
