NCT01695811

Femtosecond Laser-Assisted Keratoplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Keratoconus

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-03-01
• Completion: 2013-12-01
• First posted: 2012-09-28
• Last updated: 2015-01-21