LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser (FS200)
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|ClinicalTrials.gov Identifier: NCT02060461|
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : March 23, 2018
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: FS200 femtosecond laser LASIK Device: IntraLase femtosecond laser LASIK||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Contralateral eye study|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||William J Dupps, MD, PhD||The Cleveland Clinic|