70 vs 110 Degree Side-cut Angles in Femtosecond LASIK

Operative Incision Clinical Trial

Official title:

70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122535
• Other study ID #: IRB 74858
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Operative Incision
• Surgical Wound

Intervention

Device:
• FS-LASIK 70 degree side-cut angle
FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
• FS-LASIK 110 degree side-cut angle
FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.

Locations

Country	Name	City	State
United States	University of Utah John A. Moran Eye Center - Midvalley Location	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Visual Acuity at One Year	Vision testing without correction, both eyes using Snellen Eye chart	one year
Secondary	Best Corrected Visual Acuity at Year One	Vision testing with correction, both eyes using Snellen Eye chart	one year