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Abstract：
BACKGROUND: To compare the 4-year visual outcomes of implantable collamer lens V4c (EVO-ICL) implantation and small incision lenticule extraction (SMILE) for high myopia and astigmatism.
METHODS: This retrospective case study included 64 eyes of 40 patients. These patients with preoperative manifest refraction spherical equivalent (SE) between - 6.00 and - 10.00 diopters (D) were screened from the database of SMILE and EVO-ICL implantation procedures in 2015. The ICL group [32 eyes of 19 patients (mean age, 29.6 ± 6.3 years); mean SE, -8.71 ± 1.06 D] and SMILE group [32 eyes of 21 patients (mean age, 27.7 ± 5.6 years); mean SE, -8.35 ± 0.65D] were compared. All patients were then prospectively examined at a four-year follow-up for routine postoperative examinations, higher-order ocular aberrations, retinal image quality and a questionnaire.
RESULTS: The safety indexes were 1.15 ± 0.14 and 1.22 ± 0.21 (P = 0.36) for the SMILE and ICL groups, respectively. No eyes lost two or more lines of CDVA in either group. The efficacy indexes were 0.97 ± 0.16 and 0.96 ± 0.19 (P = 0.87), respectively. Twenty-three eyes (72%) in ICL and 26 eyes (81%) in SMILE groups were within ± 0.5 D of the attempted SE (P < 0.01). ICL-treated eyes had significantly less spherical aberration and coma (P < 0.01 and < 0.05, respectively) postoperatively. Halos were the prevalent visual disturbance in both groups.
CONCLUSIONS: SMILE and EVO-ICL implantation provided safe and effective correction of high myopia. SMILE showed slightly better long-term predictability. Mild postoperative visual disturbances were observed after ICL and SMILE at 4-year follow-up.
METHODS: This retrospective case study included 64 eyes of 40 patients. These patients with preoperative manifest refraction spherical equivalent (SE) between - 6.00 and - 10.00 diopters (D) were screened from the database of SMILE and EVO-ICL implantation procedures in 2015. The ICL group [32 eyes of 19 patients (mean age, 29.6 ± 6.3 years); mean SE, -8.71 ± 1.06 D] and SMILE group [32 eyes of 21 patients (mean age, 27.7 ± 5.6 years); mean SE, -8.35 ± 0.65D] were compared. All patients were then prospectively examined at a four-year follow-up for routine postoperative examinations, higher-order ocular aberrations, retinal image quality and a questionnaire.
RESULTS: The safety indexes were 1.15 ± 0.14 and 1.22 ± 0.21 (P = 0.36) for the SMILE and ICL groups, respectively. No eyes lost two or more lines of CDVA in either group. The efficacy indexes were 0.97 ± 0.16 and 0.96 ± 0.19 (P = 0.87), respectively. Twenty-three eyes (72%) in ICL and 26 eyes (81%) in SMILE groups were within ± 0.5 D of the attempted SE (P < 0.01). ICL-treated eyes had significantly less spherical aberration and coma (P < 0.01 and < 0.05, respectively) postoperatively. Halos were the prevalent visual disturbance in both groups.
CONCLUSIONS: SMILE and EVO-ICL implantation provided safe and effective correction of high myopia. SMILE showed slightly better long-term predictability. Mild postoperative visual disturbances were observed after ICL and SMILE at 4-year follow-up.
摘要：
背景：比较高度近视和散光的植入式晶状体V4c（EVO-ICL）植入和小切口微透镜摘除（SMILE）的4年视力结果。
方法：本回顾性病例研究包括40例患者的64只眼。2015年，从SMILE和EVO-ICL植入程序数据库中筛选出这些术前明显屈光球面当量（SE）在-6.00和-10.00屈光度（D）之间的患者。ICL组[19例患者的32只眼(平均年龄，29.6±6.3年)；平均SE，-8.71±1.06D]和SMILE组[21例患者的32只眼（平均年龄，27.7±5.6年)；平均SE，比较-8.35±0.65D]。然后，在为期四年的随访中对所有患者进行了前瞻性检查，以进行常规的术后检查。高阶眼像差，视网膜图像质量和问卷。
结果：SMILE和ICL组的安全性指数分别为1.15±0.14和1.22±0.21（P=0.36），分别。两组中都没有眼睛失去两行或更多行CDVA。疗效指数分别为0.97±0.16和0.96±0.19(P=0.87),分别。ICL组23只眼（72％）和SMILE组26只眼（81％）在尝试SE的±0.5D内（P<0.01）。ICL治疗的眼睛术后球差和慧差明显减少（分别为P<0.01和<0.05）。光晕是两组中普遍存在的视觉障碍。
结论：SMILE和EVO-ICL植入可安全有效地矫正高度近视。SMILE显示出更好的长期可预测性。在ICL和SMILE术后4年随访观察到轻度的术后视力障碍。
方法：本回顾性病例研究包括40例患者的64只眼。2015年，从SMILE和EVO-ICL植入程序数据库中筛选出这些术前明显屈光球面当量（SE）在-6.00和-10.00屈光度（D）之间的患者。ICL组[19例患者的32只眼(平均年龄，29.6±6.3年)；平均SE，-8.71±1.06D]和SMILE组[21例患者的32只眼（平均年龄，27.7±5.6年)；平均SE，比较-8.35±0.65D]。然后，在为期四年的随访中对所有患者进行了前瞻性检查，以进行常规的术后检查。高阶眼像差，视网膜图像质量和问卷。
结果：SMILE和ICL组的安全性指数分别为1.15±0.14和1.22±0.21（P=0.36），分别。两组中都没有眼睛失去两行或更多行CDVA。疗效指数分别为0.97±0.16和0.96±0.19(P=0.87),分别。ICL组23只眼（72％）和SMILE组26只眼（81％）在尝试SE的±0.5D内（P<0.01）。ICL治疗的眼睛术后球差和慧差明显减少（分别为P<0.01和<0.05）。光晕是两组中普遍存在的视觉障碍。
结论：SMILE和EVO-ICL植入可安全有效地矫正高度近视。SMILE显示出更好的长期可预测性。在ICL和SMILE术后4年随访观察到轻度的术后视力障碍。
