Comparing SMILE and SMILE Xtra procedures for myopia treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of two surgical procedures, SMILE and SMILE Xtra, in treating myopia. It aims to compare their clinical efficacy, biomechanical stability, and optical quality through a randomized controlled approach. Participants will be monitored for visual outcomes and any potential complications associated with each procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Cong Jing
• Email: lucky_congjing@163.com
• Phone: 17269769976

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.