RecruitingNot ApplicableNCT06992011
A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia
Sponsor
Shanghai Zhongshan Hospital
Enrollment
300 participants
Start Date
Feb 1, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 50 Years
Inclusion Criteria6
- Age 18-50 years
- MRSE (Manifest Refraction Spherical Equivalent) -6.00D to -10.00D with refractive changes within ±0.50D in past 2 years
- CDVA (Corrected Distance Visual Acuity) ≥ 20/25
- Myopia progression ≤ 0.50D/year for ≥2 years
- RST (Residual Stromal Thickness) ≥ 250μm after lenticule removal
- Contact lens discontinuation as per protocol
Exclusion Criteria6
- Other eye diseases (keratoconus, glaucoma, etc.)
- Corneal scarring, cataracts affecting observation
- Systemic diseases affecting surgery compliance
- Prior ocular surgeries
- Pregnancy, breastfeeding, or menstruation
- Drug allergies to surgical medication
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Interventions
PROCEDURESMILE
Small Incision Lenticule Extraction
PROCEDURESMILE Xtra
Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06992011
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