A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia
NCT ID: NCT06992011
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-02-01
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SMILE Group
SMILE
Small Incision Lenticule Extraction
SMILE Xtra Group
SMILE Xtra
Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)
Interventions
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SMILE
Small Incision Lenticule Extraction
SMILE Xtra
Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
50 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Locations
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B2024-267R-1
Identifier Type: -
Identifier Source: org_study_id
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