Comparing SMILE and SMILE Xtra Procedures for Treating High Myopia in Adults Aged 18 to 50

What this Trial Is About

Researchers are evaluating the clinical effectiveness and refractive stability of two procedures, SMILE and SMILE Xtra, in people with myopia. The study compares Small Incision Lenticule Extraction SMILE alone versus SMILE combined with Corneal Cross-linking SMILE Xtra to see which approach better manages myopia. This research is being conducted by Shanghai Zhongshan Hospital and focuses on adults aged 18 to 50 years with high myopia. Participants will be assigned to receive either the SMILE procedure or the SMILE Xtra procedure. SMILE involves the removal of a small lenticule from the cornea, while SMILE Xtra adds corneal cross-linking to this process to potentially improve stability. The study is non-randomized and does not use masking. Treatments are performed as procedures, and patients will be followed over time to assess outcomes. During the study, participants will have their visual acuity measured at multiple time points 1 week, 1 month, 6 months, 12 months, 24 months, and 36 months after the procedure. Researchers will monitor how well vision is corrected and how stable the refractive changes remain. The total duration of follow-up is three years, allowing careful assessment of long-term results. Safety and vision quality will be closely observed throughout the study period.

A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia