Overview

This trial has been completed.

Condition lasik eye surgery
Sponsor University of Michigan
Start date June 2011
End date December 2013
Trial size 51 participants
Trial identifier NCT01695642, LASIK_00049051

Summary

Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed for correction of myopia. There are very few studies that have been performed to evaluate long-term outcomes after LASIK.

In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability of visual outcomes and long-term effect on corneal morphology with in vivo confocal microscopy. Clinical and corneal morphology outcomes will also be compared between patients who had flaps created with the microkeratome and femtosecond laser.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
mechanical microkeratome
femtosecond laser

Primary Outcomes

Measure
Compare flap creation with mikrokeratome and Intralase
time frame: 8 to 10 years

Eligibility Criteria

All participants from 18 years up to 99 years old.

Inclusion Criteria: - lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of follow up after surgery Exclusion Criteria:

Additional Information

Official title Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser
Principal investigator Roni Shtein, MD, MS
Description Volunteers will be eligible for enrollment into the study if have had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior. A complete ophthalmic examination and corneal confocal microscopy will be performed. The study visit will take approximately one hour.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by University of Michigan.