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

What this Trial Is About

Researchers are conducting a randomized controlled trial to compare the clinical effectiveness, biomechanical stability, and optical quality of two procedures for treating myopia Small Incision Lenticule Extraction SMILE and SMILE combined with Corneal Cross-linking SMILE Xtra. The study aims to understand which procedure better addresses myopia in patients aged 18 to 50 years. This research is sponsored by Shanghai Zhongshan Hospital and focuses on evaluating visual outcomes over a long period. Participants will be randomly assigned to receive either the SMILE procedure or the SMILE Xtra procedure. These are both eye surgeries designed to correct myopia, with SMILE Xtra including an additional cross-linking step intended to improve corneal stability. The study will follow patients for up to 36 months after treatment to assess how well their vision improves and how stable the results remain over time. Throughout the study, participants will have their visual acuity measured at multiple timepoints 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months after surgery. This will help researchers monitor the effectiveness and safety of each procedure. Patients will also be evaluated for any complications or changes in eye health. The total participation duration can last up to three years, with regular follow-up visits to assess and compare outcomes.

A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia