Status:
RECRUITING
A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Myopia
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
To evaluate and compare the clinical efficacy, biomechanical stability, and optical quality of SMILE and SMILE Xtra procedures in patients with myopia through a randomized controlled trial
Eligibility Criteria
Inclusion
- Age 18-50 years
- MRSE (Manifest Refraction Spherical Equivalent) -6.00D to -10.00D with refractive changes within ±0.50D in past 2 years
- CDVA (Corrected Distance Visual Acuity) ≥ 20/25
- Myopia progression ≤ 0.50D/year for ≥2 years
- RST (Residual Stromal Thickness) ≥ 250μm after lenticule removal
- Contact lens discontinuation as per protocol
Exclusion
- Other eye diseases (keratoconus, glaucoma, etc.)
- Corneal scarring, cataracts affecting observation
- Systemic diseases affecting surgery compliance
- Prior ocular surgeries
- Pregnancy, breastfeeding, or menstruation
- Drug allergies to surgical medication
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06992011
Start Date
February 1 2023
End Date
February 1 2027
Last Update
May 28 2025
Active Locations (1)
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1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032