Femtosecond Laser-Assisted Keratoplasty (FLAK)
The purpose of this study will be to determine optimal surgical technique for performing FLAK including laser parameters, keratoplasty shape and suture technique in order to standardize surgical technique and to collect safety and efficacy data. This will be compared to data of patients with full thickness PKP to measure visual outcomes, refraction, astigmatism, surgical methods and wound healing.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Femtosecond Laser-Assisted Keratoplasty|
- Surgical outcomes [ Time Frame: 1 day, 1 week, 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]Wound healing, surgical complications, visual function and endothelial layer assessment
|Study Start Date:||November 2007|
|Study Completion Date:||December 2013|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
FLAK Instrument: The Femtosecond Laser (IntraLase Corporation, Irvine, CA) is a focusable infrared laser, similar to the more familiar neodymium-yttrium-aluminum-garnet (YAG) laser, but uses shorter pulses in the hundred-femtosecond (100 X 10-15 seconds) duration range. There is minimal postoperative inflammation and collateral tissue damage.
Subjects: We will be enrolling subjects 18 years or older that need keratoplasty based on clinical findings. Subjects will be enrolled regardless of race or gender on a first come first serve basis. Subjects will be recruited from the physicians own clinic.
PKP Subjects: We will do a retrospective chart review on subjects who have undergone traditional PKP. FLAK eyes will be age and gender matched to these PKP eyes to compare visual outcomes, wound healing and complications.
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