Department of Ophthalmology, Philipps University of Marburg, Robert-Koch-Strasse 4, 35037 Marburg, Germany.
Br J Ophthalmol. 2011 Mar;95(3):335-9. doi: 10.1136/bjo.2009.174284. Epub 2010 Jul 3.
This 6 month prospective multi-centre study evaluated the feasibility of performing myopic femtosecond lenticule extraction (FLEx) through a small incision using the small incision lenticule extraction (SMILE) procedure.
Prospective, non-randomised clinical trial. PARTICIPANTS; Ninety-one eyes of 48 patients with myopia with and without astigmatism completed the final 6 month follow-up. The patients' mean age was 35.3 years. Their preoperative mean spherical equivalent (SE) was −4.75±1.56 D.
A refractive lenticule of intrastromal corneal tissue was cut utilising a prototype of the Carl Zeiss Meditec AG VisuMax femtosecond laser system. Simultaneously two opposite small ‘pocket’ incisions were created by the laser system. Thereafter, the lenticule was manually dissected with a spatula and removed through one of incisions using modified McPherson forceps.
Uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA) after 6 months, objective and manifest refraction as well as slit-lamp examination, side effects and a questionnaire.
Six months postoperatively the mean SE was −0.01 D±0.49 D. Most treated eyes (95.6%) were within ±1.0 D, and 80.2% were within ±0.5 D of intended correction. Of the eyes treated, 83.5% had an UCVA of 1.0 (20/20) or better, 53% remained unchanged, 32.3% gained one line, 3.3% gained two lines of BSCVA, 8.8% lost one line and 1.1% lost ≥2 lines of BSCVA. When answering a standardised questionnaire, 93.3% of patients were satisfied with the results obtained and would undergo the procedure again.
SMILE is a promising new flapless minimally invasive refractive procedure to correct myopia.
本为期 6 个月的多中心前瞻性研究评估了通过小切口利用小切口微透镜提取（SMILE）手术进行近视飞秒微透镜提取（FLEx）的可行性。
前瞻性、非随机临床试验。
48 名近视伴或不伴散光患者的 91 只眼完成了最终的 6 个月随访。患者的平均年龄为 35.3 岁。他们术前平均等效球镜（SE）为−4.75±1.56 D。
利用卡尔蔡司 Meditec AG VisuMax 飞秒激光系统的原型切割基质内屈光性透镜组织。同时，激光系统创建了两个相对的小“口袋”切口。此后，用解剖刀手动解剖透镜，并通过其中一个切口用改良的麦克弗森镊子取出。
术后 6 个月时的未矫正视力（UCVA）和最佳矫正视力（BSCVA）、客观和主观屈光以及裂隙灯检查、副作用和问卷调查。
术后 6 个月时，平均 SE 为−0.01 D±0.49 D。大多数治疗眼（95.6%）在±1.0 D 以内，80.2%在±0.5 D 以内。在接受治疗的眼中，83.5%的 UCVA 为 1.0（20/20）或更好，53%保持不变，32.3%提高一行，3.3%提高两行 BSCVA，8.8%下降一行，1.1%下降≥2 行 BSCVA。在回答标准化问卷时，93.3%的患者对获得的结果满意，并愿意再次接受该手术。
SMILE 是一种有前途的新型无瓣微创屈光手术，可矫正近视。
