Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03122535 |
Other study ID # |
IRB 74858 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 7, 2014 |
Est. completion date |
March 21, 2019 |
Study information
Verified date |
May 2021 |
Source |
University of Utah |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare 70 and 110 degree side-cut angles on the same patient
undergoing Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK).
Description:
LASIK has become the preferred corneal procedure to correct certain refractive errors. One of
the major advancements in LASIK has been the introduction of Femtosecond Laser technology for
flap creation. Several studies have compared microkeratome and femtosecond laser technology,
showing superior accuracy and precision of flap dimensions in the latter.
The Femtosecond Laser technology provides different parameters and settings that can be
changed according to the surgeon's preference. One of such parameters is the side-cut angle.
Some of the most common side-cut angles used today include 45, 70, 90, and 110 degrees.
Previous studies have reported on the visual outcomes of side-cut angles, but head to head
comparisons are lacking. Currently, there are no studies comparing the safety and efficacy of
the 70 and 110 side-cut angles in FS-LASIK. Information regarding the outcomes and
complication rates between these side-cut angles will provide an objective measure that can
be used when deciding which one is more suitable in FS-LASIK.
One angle will be performed on the right eye and the other on the left eye. The study will
evaluate uncorrected visual acuity, best corrected visual acuity, intraoperative, and
postoperative complications. Performing different side-cut angles on the same individual will
allow a direct comparison of outcomes, minimizing confounding variables.