Overview

This trial is active, not recruiting.

Condition myopia
Treatment fs200 laser
Sponsor The Cleveland Clinic
Start date August 2012
End date September 2015
Trial size 32 participants
Trial identifier NCT02060461, 11-744

Summary

Laser in situ keratomileusis (LASIK) is a safe and effective method for treating myopia, hyperopia and astigmatism. It is based on reshaping the cornea to focus the light closer to the macula. This method includes two steps: a corneal flap creation, which can be performed by a mechanical microkeratome or a femtosecond laser, and the reshaping of the cornea by another laser (Excimer laser).

The corneal flap creation is a crucial step. Indeed, creating a flap weakens a large part of the anterior stroma. The accuracy of the LASIK flap thickness is a key safety consideration to reduce the likelihood of ectasia following LASIK. Femtosecond laser technology has significantly improved the results of LASIK flaps, with increased predictability, lesser induction of optical aberrations, and a better healing profile compared to microkeratome flaps, with similar visual acuity results.

Femtosecond Laser technology has been extensively investigated for the last ten years for use in refractive surgery. Actually, four femtosecond laser devices are available to perform LASIK flaps, each of them having clinical benefits and limitations. A fifth, designed by WaveLight AG/Alcon Laboratories, Inc. (Erlangen, Germany/Fort Worth, Texas), is approved for human use by the United States Food and Drug Administration and has been just released in the US market. Its unique technical aspects, optimized scanning algorithms, and user-friendly patient interface, have already provided a high reproducibility for cutting three-dimensional tissues structures in porcine corneas. Furthermore, the device has been shown to minimize opaque bubble layer (OBL) formation. This condition is very common and responsible for a delay in the treatment, since it can obstruct the eye tracker.

The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the new 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
fs200 laser

Primary Outcomes

Measure
Evaluation of visual outcome accuracy and LASIK Flap thickness
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser: 3 Months Follow-up of Initial US Clinical Series
Principal investigator William J Dupps, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.