70 vs 110 Degree Side-cut Angles in Femtosecond LASIK

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Operative Incision

Treatments: Device: FS-LASIK 110 degree side-cut angle; Device: FS-LASIK 70 degree side-cut angle

Study type: Interventional

Funder types: Other

Identifiers

NCT03122535

IRB 74858

Details and patient eligibility

About

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).

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups

FS-LASIK 70 degree side-cut angle

Active Comparator group

Description:

Each 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.

Treatment:

Device: FS-LASIK 110 degree side-cut angle

Device: FS-LASIK 70 degree side-cut angle

FS-LASIK 110 degree side-cut angle

Active Comparator group

Description:

Each 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.

Treatment:

Device: FS-LASIK 110 degree side-cut angle

Device: FS-LASIK 70 degree side-cut angle