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70 vs 110 Degree Side-cut Angles in Femtosecond LASIK

Not Applicable
Completed
Conditions
Operative Incision
Interventions
Device: FS-LASIK 70 degree side-cut angle
Device: FS-LASIK 110 degree side-cut angle
Registration Number
NCT03122535
Lead Sponsor
University of Utah
Brief 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).

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
115
Inclusion Criteria
  • Subjects who are deemed suitable candidates for bilateral LASIK will be considered eligible for participation in this study. Correction will be distance for both eyes.
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Exclusion Criteria
  • Selection will be consistent with current standard of care. Any patient that is not a suitable candidate for LASIK will not be included.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
FS-LASIK 110 degree side-cut angleFS-LASIK 110 degree side-cut angleEach patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angleFS-LASIK 70 degree side-cut angleEach patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angleFS-LASIK 110 degree side-cut angleEach patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 110 degree side-cut angleFS-LASIK 70 degree side-cut angleEach patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
Primary Outcome Measures
NameTimeMethod
Uncorrected Visual Acuity at One Yearone year

Vision testing without correction, both eyes using Snellen Eye chart

Secondary Outcome Measures
NameTimeMethod
Best Corrected Visual Acuity at Year Oneone year

Vision testing with correction, both eyes using Snellen Eye chart

Trial Locations

Locations (1)

University of Utah John A. Moran Eye Center - Midvalley Location

🇺🇸

Murray, Utah, United States

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