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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: FS200 femtosecond laser LASIK; Device: IntraLase femtosecond laser LASIK

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FS200 femtosecond laser LASIK; LASIK flap created with an FS200 femtosecond laser system	Device: FS200 femtosecond laser LASIK; Other Names: Alcon FS200 femtosecond laser
EXPERIMENTAL: IntraLase femtosecond laser LASIK; LASIK flap created with an IntraLase femtosecond laser system	Device: IntraLase femtosecond laser LASIK; Other Names: AMO IntraLase femtosecond laser

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Alcon Research
• Investigators: Principal Investigator: William J Dupps, MD, PhD, The Cleveland Clinic

Publications and helpful links

General Publications

• Rocha KM, Krueger RR. Spectral-domain optical coherence tomography epithelial and flap thickness mapping in femtosecond laser-assisted in situ keratomileusis. Am J Ophthalmol. 2014 Aug;158(2):293-301.e1. doi: 10.1016/j.ajo.2014.04.012. Epub 2014 Apr 30.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (ESTIMATE): February 12, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 11-744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No