International Multicenter Study on SMILE Surgery (NCT02844556) | Clinical Trial Compass
UnknownNot Applicable
International Multicenter Study on SMILE Surgery
China1,000 participantsStarted 2016-09
Plain-language summary
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
Who can participate
Age range18 Years – 45 Years
SexALL
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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.
What they're measuring
1
corrected visual acuity
Timeframe: change from baseline with EDTRS chart at 6 months