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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02060461
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myopia Device: FS200 femtosecond laser LASIK Device: IntraLase femtosecond laser LASIK Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Contralateral eye study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser: 3 Months Follow-up of Initial US Clinical Series
Study Start Date : August 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FS200 femtosecond laser LASIK
LASIK flap created with an FS200 femtosecond laser system
Device: FS200 femtosecond laser LASIK
Other Name: Alcon FS200 femtosecond laser

Experimental: IntraLase femtosecond laser LASIK
LASIK flap created with an IntraLase femtosecond laser system
Device: IntraLase femtosecond laser LASIK
Other Name: AMO IntraLase femtosecond laser




Primary Outcome Measures :
  1. Evaluation of LASIK Flap Thickness [ Time Frame: 3 months ]
    Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060461


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Alcon Research
Investigators
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Principal Investigator: William J Dupps, MD, PhD The Cleveland Clinic

Publications of Results:
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02060461     History of Changes
Other Study ID Numbers: 11-744
First Posted: February 12, 2014    Key Record Dates
Results First Posted: March 23, 2018
Last Update Posted: March 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No