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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: IntraLase femtosecond laser LASIK; Device: FS200 femtosecond laser LASIK

• Registration Number: NCT02060461
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Primary Completion: 2015-09
• Study Completion: 2016-09
• Results First Submitted: 2017-01-23
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Results First Posted: 2018-03-23
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IntraLase femtosecond laser LASIK	IntraLase femtosecond laser LASIK	LASIK flap created with an IntraLase femtosecond laser system
FS200 femtosecond laser LASIK	FS200 femtosecond laser LASIK	LASIK flap created with an FS200 femtosecond laser system

Primary Outcome Measures

Name	Time	Method
Evaluation of LASIK Flap Thickness	3 months	Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States