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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different eye surgery techniques called SMILE and SMILE Xtra, which are used to treat myopia, or nearsightedness. The goal is to find out which method works better in terms of improving vision, stability of the eye after surgery, and overall visual quality. The study is currently recruiting participants aged 18 to 50 who have specific degrees of myopia and have not experienced significant changes in their vision for the past two years.

To be eligible for this trial, individuals should have a certain level of vision correction and meet other health criteria, such as not having major eye diseases or having had previous eye surgeries. Participants can expect to undergo one of the two surgical procedures and will be monitored for their recovery and vision improvement. This study is important because it may help determine the best option for people looking to correct their nearsightedness safely and effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-50 years
• • 2. MRSE (Manifest Refraction Spherical Equivalent) -6.00D to -10.00D with refractive changes within ±0.50D in past 2 years
• • 3. CDVA (Corrected Distance Visual Acuity) ≥ 20/25
• • 4. Myopia progression ≤ 0.50D/year for ≥2 years
• • 5. RST (Residual Stromal Thickness) ≥ 250μm after lenticule removal
• • 6. Contact lens discontinuation as per protocol
• Exclusion Criteria:
• • 1. Other eye diseases (keratoconus, glaucoma, etc.)
• • 2. Corneal scarring, cataracts affecting observation
• • 3. Systemic diseases affecting surgery compliance
• • 4. Prior ocular surgeries
• • 5. Pregnancy, breastfeeding, or menstruation
• • 6. Drug allergies to surgical medication