Myopia
Conditions
Brief summary
To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
Interventions
PROCEDURESMILE
Small Incision Lenticule Extraction
PROCEDURESMILE Xtra
Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 50 years. 2. High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D～-10.00D and refractive changes within ± 0.50D in the past two years; 3. Best corrected distance visual acuity (CDVA) ≥ 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) ≥ 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity | 1 week, 1 month, 6 months, 12 months，24 months and 36 months |
Countries
China
Contacts
Primary ContactCong Jing
Outcome results
None listed