Clinical trial NCT02060461: LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser
Official title: LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser: 3 Months Follow-up of Initial US Clinical Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2014-02-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Contralateral eye study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of LASIK Flap Thickness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: William J Dupps, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.