Status:
RECRUITING
A Prospective Study on Clinical Effectiveness After 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 the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06973278
Start Date
February 1 2023
End Date
February 1 2027
Last Update
May 15 2025
Active Locations (1)
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1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032