Refractive Error Clinical Trial
Official title:
International Multicenter Study on Small Incision Lenticule Extraction(SMILE) Surgery
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
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.
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