International Multicenter Study on Small Incision Lenticule Extraction(SMILE) Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- corrected visual acuity
研究概览
简要总结
The purpose of this study is to carry out an international multicenter trial to get more convincing and valuable results of the SMILE surgery and compare the outcomes between the SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis) surgery.
The investigators hope to investigate the differences between the SMILE and the FS-LASIK surgery comprehensively, including the comparison of visual acuity, refraction, the correction of cylindrical diopter, the high order aberrations, the corneal biomechanics, the corneal ectasia, the characteristics of the changes of central corneal thickness and the complications. To meet the demands of a multi center trial, all the examination equipments should be same in each center, and this will limit the variations within a study
详细描述
Hypothesis: To compare the novel refractive surgery (SMILE, the intervention group) with traditional refractive surgery (FS-LASIK, the control group) in terms of visual acuity, the higher order aberrations, corneal biomechanical parameters and the complications. SMILE surgery might offer some advantages in some aspects compared with FS-LASIK surgery.
Study program
The procedures of the study are listed as follows:
All the participants accept the refractive surgery which were selected at first, and patients' routine postoperative examinations included UCVA, BCVA, slit lamp microscopy, non-contact IOP, corneal topography with the Scheimpflug tomography system, ocular higher order aberrations using the WASCA analyzer (Carl Zeiss Meditec AG), corneal biomechanical properties acquired by the Ocular Response Analyzer and/or the Corvis ST (Corvis ST, OCULUS, Wetzlar, Germany) at 1 week, 1 month, 3 months and 6 months follow-up periods after surgery.
Statistics:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
- •at baseline, be within the age range of 18 to 45 years old inclusive
- •normal corneal morphology with no corneal nebula or corneal macula, the range of preoperative K2 (the steep curvature of the 3mm area at the center of cornea) from 38.0 to 47.0 diopter
- •manifest spherical equivalent of -1.0 to -10.0 diopters (D)
- •cylindrical diopter no more than -5.0D
- •refractive diopter maintained stable for more than2 years
- •preoperative BCVA≥0.8, and the scotopic pupil diameter≥5.0mm when measured by WASCA analyzer (Carl Zeiss Meditec AG)
- •picked off soft contact lens for more than 2 weeks
- •picked off RGP for more than 1 month
- •preoperative corneal central thickness measured by Pentacam >500μm, non-contact IOP<21mmHg
- •be willing to comply with the clinical trial visit schedule as directed by the investigator.
排除标准
- •any corneal diseases, corneal operations, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
- •corneal macula and obvious pannus; current enrolment in another clinical trial/research project.
研究组 & 干预措施
SMILE surgery
Small incision lenticule extraction (SMILE) has become a novel and effective method for the correction of myopia and myopic astigmatism. It is a micro-invasive and flapless refractive procedure that has been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.
干预措施: SMILE surgery (Procedure)
FS-LASIK surgery
FS-LASIK surgery is femtosecond laser assisted- conventional refractive surgery and has also been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.
干预措施: FS-LASIK surgery (Other)
结局指标
主要结局
corrected visual acuity
时间窗: change from baseline with EDTRS chart at 6 months
次要结局
- central corneal thickness(change from baseline with the Pentacam system at 6 months)
- deformation amplitude assessed by the Corvis ST system(change from baseline at 6 months)
- spherical aberration(change from baseline with the WASCA system at 6 months)
- corneal hysteresis assessed by the Ocular Response Analyzer(change from baseline at 6 months)
- uncorrected visual acuity(change from baseline with EDTRS chart at 6 months)
- spherical diopter(change from baseline with manifest refraction at 6 months)
- cylindrical dioptor(change from baseline with manifest refraction at 6 months)
- corneal curvature assessed by the Pentacam system(change from baseline with mean Pentacam keratometry at 6 months)
- corneal resistance factor assessed by the Ocular Response Analyzer(change from baseline at 6 months)
- coma aberration(change from baseline with the WASCA system at 6 months)
- complication(intraoperative and postoperative at 6 months)