LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Contralateral eye study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FS200 femtosecond laser LASIK

LASIK flap created with an FS200 femtosecond laser system

Group Type EXPERIMENTAL

FS200 femtosecond laser LASIK

Intervention Type DEVICE

IntraLase femtosecond laser LASIK

LASIK flap created with an IntraLase femtosecond laser system

Group Type EXPERIMENTAL

IntraLase femtosecond laser LASIK

Intervention Type DEVICE

Interventions

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FS200 femtosecond laser LASIK

Intervention Type DEVICE

IntraLase femtosecond laser LASIK

Intervention Type DEVICE

Other Intervention Names

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Alcon FS200 femtosecond laser AMO IntraLase femtosecond laser

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No