Myopia
Conditions
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
Interventions
PROCEDURESMILE
Small Incision Lenticule Extraction
PROCEDURESMILE Xtra
Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity | 1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months |
Countries
China
Contacts
Primary ContactCong Jing
Outcome results
None listed