refractive errors
Conditions
Interventions
Group SMILE PRO:None
Group FS-LASIK:None
Sponsors
Nanchang Bright Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible for inclusion: 1. Age: Between 18 and 45 years old (inclusive), with full legal capacity. 2. Refractive Status: Preoperative astigmatism (cylinder) between -2.00 D and -4.00 D. Preoperative spherical equivalent (SE) between -1.00 D and -10.00 D. Stable refractive status (SE change = 20/25. Central corneal thickness >= 480 µm, with a predicted postoperative residual stromal bed thickness >= 280 µm. Corneal topography excludes clinical or subclinical keratoconus. Normal intraocular pressure, open angle, and no history of glaucoma. No active ocular diseases or fundus pathologies affecting vision. 4. Informed Consent: Full understanding of the study content, voluntary participation, and signed informed consent.
Exclusion criteria
Exclusion criteria: Meeting any one of the following criteria will result in exclusion from the study: 1. Systemic Diseases: Autoimmune diseases, connective tissue diseases, uncontrolled diabetes, immunodeficiency diseases, pregnancy, or breastfeeding. 2. Ocular History: History of prior intraocular surgery or corneal surgery, active ocular diseases, corneal scars, cataracts, lens subluxation, history of retinal detachment, etc. 3. Abnormal Corneal Conditions: Presence of corneal dystrophy, corneal endothelial cell density < 2000 cells/mm², suspected or confirmed keratoconus. 4. Medications and Habits: Current use of systemic medications that may affect wound healing or vision; history of drug abuse or alcoholism. 5. Poor Compliance: Inability to complete the scheduled follow-up visits as planned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute residual cylinder at 3 months postoperatively;Proportion of eyes with spherical equivalent within ±0.50 D at 3 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best-corrected distance visual acuity (logMAR);Spherical equivalent (SE);Astigmatic correction vector analysis parameters;Total higher-order aberrations RMS value;Spherical Aberration;Vertical Coma;Horizontal Coma;Horizontal Trefoil;Oblique Trefoil;Intraocular Pressure (IOP);Intraoperative Decentration Distance;Intraoperative Decentration Direction;Quality of Vision (QoV) Questionnaire Score;Contrast sensitivity;Refractive stability; | — |
Countries
China
Contacts
Public ContactHui Zhang
Nanchang Bright Eye Hospital
Outcome results
None listed