International Multicenter Study on SMILE Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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: Patients who have decided to choose the SMILE surgery or the FS-LASIK will be selected as participants. The propensity matching method will be used to choose proper cases for the two groups. The propensity matching method can be calculated by SPSS software. The independent variables include: the central corneal thickness (CCT), the Km (mean Pentacam keratometry), the spherical diopter (from manifest refraction), and the cylindrical diopter (from manifest refraction), the UCVA, the BCVA, the corneal resistance factor (CRF) and the corneal hysteresis (CH) (if the investigator have the Ocular Response Analyzer) of the cornea at preoperative. The closest score of eyes in the two groups will be matched. The data will be preserved by each site, and will be systematically collected and analyzed by TianjinEH center. The statistical expert Dr Hayes from American Pacific University will be the statistical consultant, and will also in charge of the sample size calculation, the instructor of statistical analysis, and the quality control.

Official Title
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International Multicenter Study on Small Incision Lenticule Extraction(SMILE) Surgery

Conditions
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Refractive Error

Intervention / Treatment
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* Procedure: SMILE surgery
* Other: FS-LASIK surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SMILE surgery<br>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. | Procedure: SMILE surgery<br>* SMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.<br>|
| Other: FS-LASIK surgery<br>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. | Other: FS-LASIK surgery<br>* SMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corrected visual acuity |  | change from baseline with EDTRS chart at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| central corneal thickness |  | change from baseline with the Pentacam system 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 | 
| corneal hysteresis assessed by the Ocular Response Analyzer |  | change from baseline 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 | 
| coma aberration |  | change from baseline with the WASCA system at 6 months | 
| complication |  | intraoperative and postoperative at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMILE surgery, FS-LASIK surgery, multicenter