LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 2012 |
| End Date: | September 2016 |
LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser: 3 Months Follow-up of Initial US Clinical Series
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.
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.
Laser in situ keratomileusis (LASIK) is a method for treating myopia, hyperopia and
astigmatism. In LASIK, the cornea is reshaped to focus images more clearly on the retina
without the aid of glasses or contact lenses. LASIK involves two steps: creation of a corneal
flap, which can be performed by a mechanical microkeratome or a femtosecond laser, and
reshaping of the cornea by another laser, an excimer laser.
The accuracy of the LASIK flap thickness is a key safety consideration to reduce the
likelihood of complications following LASIK. Femtosecond laser technology has significantly
improved the predictability of LASIK flap dimensions while supporting similar visual acuity
results.
The Alcon FS200 femtosecond laser is approved for human use by the United States Food and
Drug Administration and was recently released in the US market. This study will directly
compare outcomes of LASIK performed with this newer laser to those performed with the AMO
IntraLase femtosecond laser.
astigmatism. In LASIK, the cornea is reshaped to focus images more clearly on the retina
without the aid of glasses or contact lenses. LASIK involves two steps: creation of a corneal
flap, which can be performed by a mechanical microkeratome or a femtosecond laser, and
reshaping of the cornea by another laser, an excimer laser.
The accuracy of the LASIK flap thickness is a key safety consideration to reduce the
likelihood of complications following LASIK. Femtosecond laser technology has significantly
improved the predictability of LASIK flap dimensions while supporting similar visual acuity
results.
The Alcon FS200 femtosecond laser is approved for human use by the United States Food and
Drug Administration and was recently released in the US market. This study will directly
compare outcomes of LASIK performed with this newer laser to those performed with the AMO
IntraLase femtosecond laser.
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.
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