A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia
Not Applicable
Recruiting
- Conditions
- Myopia
- Registration Number
- NCT06973278
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Age between 18 and 50 years.
- High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D～-10.00D and refractive changes within ± 0.50D in the past two years;
- Best corrected distance visual acuity (CDVA) ≥ 20/25.
- Preoperative refractive status is stable (myopia progression not exceeding 0.50D per year for at least 2 years).
- Predicted residual stromal thickness (RST) ≥ 250μm after lenticule removal. 6.Soft contact lenses discontinued for at least 1 week, rigid contact lenses for at least 3 weeks, and orthokeratology lenses for at least 3 months.
Exclusion Criteria
- The presence of other eye diseases: keratoconus or suspected keratoconus, active keratoconjunctivitis, severe dry eye, glaucoma, retinal diseases such as retinal tears or macular degeneration, etc.,
- The presence of significant corneal scarring or cataracts affects observation.
- Systemic diseases such as active systemic inflammation, connective tissue diseases, other conditions that prevent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method visual acuity 1 week, 1 month, 6 months, 12 months，24 months and 36 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China