A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia
To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
| Condition(s) | Myopia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia |
| Who can participate | 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 macula |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Lead sponsor | Shanghai Zhongshan Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2023-02-01 |
| NCT ID | NCT06973278 |
| Official listing | https://clinicaltrials.gov/study/NCT06973278 |