Myopia
Conditions
Interventions
VM800 group:SMILE surgery is performed using the VISUMAX 800 femtosecond laser device
VM500 group:SMILE surgery is performed using the VISUMAX 500 femtosecond laser device
Sponsors
Hangzhou Xihu Zhijiang Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-40 years, male or female; 2. Stable refractive error, with no more than 0.5D change within one year; 3. Corrected visual acuity >= 5.0; 4. Myopia below -10.00D, astigmatism below 5.00D; 5. Discontinued use of soft contact lenses for at least 1 week, rigid gas-permeable lenses for at least 3 weeks, or orthokeratology lenses for at least 3 months; 6. Residual corneal stromal thickness >280µm; 7. Able to comprehend the trial objectives, voluntarily participate, and provide signed informed consent by the patient or their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Keratoconus or suspected keratoconus; 2. Complicated with other ocular diseases before surgery, such as severe dry eye, progressive or acute ophthalmic diseases; 3. Concurrent systemic diseases including systemic lupus erythematosus, connective tissue disorders, or psychiatric conditions; 4. Need for combined ophthalmic surgeries that may affect the results of this study; 5. Participation in other clinical trials of medical devices within 30 days prior to screening; 6. Pregnant or lactating women; 7. Other circumstances deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Optical Zone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Q-value of the anterior corneal surface;Decentration value;Change in Q-value of the anterior corneal surface;Diopters;Change in mean corneal curvature;UCVA ( Uncorrected Visual Acuity );Corneal ablation ratio (ablation depth / central corneal thickness);BCVA (Best Corrected Visual Acuity); | — |
Countries
China
Contacts
Public ContactGuofu Chen
Hangzhou Xihu Zhijiang Eye Hospital
Outcome results
None listed