Creating LASIK Flaps With the LenSx Femtosecond Laser
This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.
Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.
Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.|
- Ease of Lifting Flaps [ Time Frame: Operative ] [ Designated as safety issue: Yes ]
0 - Unable to lift flap
- - Able to lift flap with aid of sharp instrument
- - Able to lift flap with difficulty using blunt instrument
- - Able to lift flap with moderate resistance using blunt instrument
- - Able to lift flap with minimal resistance using blunt instrument
- - Able to lift flap without any resistance using blunt instrument (Scale)
- Stromal Bed Quality [ Time Frame: Operative ] [ Designated as safety issue: Yes ]
0 - very rough
1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)
|Study Start Date:||April 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
LASIK Flap Arm
This is a single arm study.
Device: LenSx Laser
The LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556893
|Department of Ophthalmology, Semmelweis University|
|Budapest, Hungary, 1085|