70 vs 110 Degree Side-cut Angles in Femtosecond LASIK
Primary Purpose
Operative Incision
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FS-LASIK 70 degree side-cut angle
FS-LASIK 110 degree side-cut angle
Sponsored by
About this trial
This is an interventional other trial for Operative Incision focused on measuring Femtosecond LASIK (FS--LASIK), Visual acuity, Refractive errors, Side-cut angles
Eligibility Criteria
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.
Sites / Locations
- University of Utah John A. Moran Eye Center - Midvalley Location
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
FS-LASIK 70 degree side-cut angle
FS-LASIK 110 degree side-cut angle
Arm 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.
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.
Outcomes
Primary Outcome Measures
Uncorrected Visual Acuity at One Year
Vision testing without correction, both eyes using Snellen Eye chart
Secondary Outcome Measures
Best Corrected Visual Acuity at Year One
Vision testing with correction, both eyes using Snellen Eye chart
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03122535
Brief Title
70 vs 110 Degree Side-cut Angles in Femtosecond LASIK
Official Title
70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 7, 2014 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
March 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Operative Incision
Keywords
Femtosecond LASIK (FS--LASIK), Visual acuity, Refractive errors, Side-cut angles
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Each participant 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
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FS-LASIK 70 degree side-cut angle
Arm Type
Active Comparator
Arm 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.
Arm Title
FS-LASIK 110 degree side-cut angle
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
FS-LASIK 70 degree side-cut angle
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
FS-LASIK 110 degree side-cut angle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Uncorrected Visual Acuity at One Year
Description
Vision testing without correction, both eyes using Snellen Eye chart
Time Frame
one year
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity at Year One
Description
Vision testing with correction, both eyes using Snellen Eye chart
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Mifflin, MD
Organizational Affiliation
University of Utah Moran Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah John A. Moran Eye Center - Midvalley Location
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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70 vs 110 Degree Side-cut Angles in Femtosecond LASIK
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