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โ† Trials
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A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia

RecruitingNAAges 18 Years - 50 YearsAllShanghai Zhongshan Hospital
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In plain words

What the trial is, and whether it could suit you

To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age between 18 and 50 years. 2. High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D๏ฝž-10.00D and refractive changes within ยฑ 0.50D in the past two years; 3. Best corrected distance visual acuity (CDVA) โ‰ฅ 20/25. 4. Preoperative refractive status is stable (myopia progression not exceeding 0.50D per year for at least 2 years). 5. Predicted residual stromal thickness (RST) โ‰ฅ 250ฮผm 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: 1. 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., 2. The presence of significant corneal scarring or cataracts affects observation. 3. Systemic diseases such as active systemic inflammation, connective tissue diseases, other conditions that prevent
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What it tests

  • SMILE
  • SMILE Xtra
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Where

1 site
Zhongshan Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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