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 range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
corrected visual acuity
Timeframe: change from baseline with EDTRS chart at 6 months