Recruiting NCT06973278
A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SMILE, SMILE Xtra.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
Interventions
- Procedure SMILE
Small Incision Lenticule Extraction - Procedure SMILE Xtra
Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)
Primary outcome measures
- visual acuity [Time frame: 1 week, 1 month, 6 months, 12 months，24 months and 36 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital — Shanghai
Identifiers
NCT: NCT06973278 · B2024-267R