N/A
Completed N=33
LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser
Source: ClinicalTrials.gov NCT02060461 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Evaluation of LASIK Flap Thickness — 105.8; 112.9 micrometers — p=.003
Summary
The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The primary outcome to be evaluated is the flap thickness accuracy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of LASIK Flap Thickness |
105.8; 112.9 | .003 sig |
Eligibility Criteria
Inclusion Criteria
- All patients with ametropia (Spherical, spherocylindrical, presbyopic) suitable for treatment by LASIK, including different target refractions (Plano or Monovision).
Exclusion Criteria
- Patients unsuitable for LASIK procedure because of an estimated residual stromal bed < 300 microns after calculation of the ablation (Corneal thickness - flap thickness - simulated stromal ablation for the desired correction).
- Patients unsuitable for LASIK due suspicious topography for ectasia, form frust keratoconus or unstable ( more than 0.50 diopter change in sphere or cylinder in the last year) refraction.
- Patients with amblyopia or any eye disease that might limit the visual recovery.
- Patients younger than 18 years old.
Data sourced from ClinicalTrials.gov (NCT02060461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.