Femtosecond Laser-Assisted Keratoplasty (FLAK)
|ClinicalTrials.gov Identifier: NCT01695811|
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : January 21, 2015
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Observational Model:||Case Control|
|Official Title:||Femtosecond Laser-Assisted Keratoplasty|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||December 2013|
- Surgical outcomes [ Time Frame: 1 day, 1 week, 1, 3, 6, 12, 18 and 24 months ]Wound healing, surgical complications, visual function and endothelial layer assessment