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

NCT06992011 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Not applicable

Started

2023-02-01

Last updated

2025-05-28

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

SMILESMILE Xtra

SMILE: Small Incision Lenticule Extraction

SMILE Xtra: Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)

Study 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

Sex

ALL

Min age

18 Years

Max age

50 Years

Healthy volunteers

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

Primary outcome measure(s)

visual acuity — 1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months

Trial sites (1)

Facility	City	Region	Status
Zhongshan Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06992011 on ClinicalTrials.gov ↗ ← All trials in China