Refractive error correction Eye Diseases
Conditions
Interventions
All participants are treated for correction of myopia with or without astigmatism. The intervention will be either raytracing optimised LASIK or Smile Pro, both laser-assisted lamellar procedures on t
Sponsors
Alcon Greece
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 45 years 2. Stable myopia or myopic astigmatism for at least 12 months before surgery, within the following limits: Preoperative myopia from -1 to -8 D (minimum spherical equivalent -2D) and up to -3 D of astigmatism. Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months before surgery, verified by consecutive subjective refractions or medical records or prescription history. 3. Preoperative corrected distance visual acuity (CDVA) of 20/20 or better in both eyes 4. Minimum central corneal thickness of 500µm 5. Absence of ocular surface disease or significant dry eye 6. Willingness to comply with the postoperative follow-up schedule
Exclusion criteria
Exclusion criteria: 1. Anisometropia >1D in sphere and >0.5D cylinder between the eyes 2. History of ocular surgery or trauma 3. History or clinical evidence of dry eye. 4. Evidence of corneal ectatic disorders such as keratoconus or pellucid marginal degeneration 5. Presence of corneal scars, opacity, or other structural abnormalities 6. Active ocular inflammation or infection 7. Systemic conditions affecting wound healing (e.g., uncontrolled diabetes, autoimmune disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lines of vision gained, comparing preoperative best corrected distance acuity, measured using data collected from patient records, measured at baseline and 3 months following each procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. % of eyes with defocus equivalent within ±0.25D, ±0.50D, ±0.75 and ±1.0D measured using subjective manifest refraction at baseline and 3 months 2. % of eyes with absolute MRSE (manifest refraction spherical equivalent) within ±0.25D, ±0.5D, ±0.75 and ±1.0D measured using subjective manifest refraction again at baseline and 3 months 3. % of eyes with UCDVA and BCDVA of 20/10, 20/12.5, 20/16, 20/20, 20/25, 20/32, or better measured using subjective manifest refraction at baseline and 3 months 4. Lines of vision gained in LogMAR (defined as the change in pre-CDVA to post-op CDVA (1 week and 1 month) and pre-CDVA to post UDVA at all time points), measured using subjective manifest refraction at baseline and 3 months | — |
Countries
Greece
Contacts
Public ContactAnastasios John Kanellopoulos
Outcome results
None listed