RecruitingNot ApplicableNCT06973278

A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia

Sponsor

Shanghai Zhongshan Hospital

Enrollment

200 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 50 Years

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.

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

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