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

Not Applicable

Recruiting

• Conditions: Myopia

• Registration Number: NCT06992011
• Lead Sponsor: Shanghai Zhongshan Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
visual acuity	1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China