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70 vs 110 Degree Side-cut Angles in Femtosecond LASIK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03122535
Recruitment Status : Unknown
Verified May 2018 by Mark Mifflin, University of Utah.
Recruitment status was:  Recruiting
First Posted : April 20, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Mifflin, 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).

Condition or disease Intervention/treatment Phase
Operative Incision Device: FS-LASIK 70 degree side-cut angle Device: FS-LASIK 110 degree side-cut angle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Primary Purpose: Other
Official Title: 70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis
Actual Study Start Date : October 7, 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Active Comparator: FS-LASIK 70 degree side-cut angle
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.
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.

Device: 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.

Active Comparator: FS-LASIK 110 degree side-cut angle
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.
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.

Device: 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.




Primary Outcome Measures :
  1. Change in manifest refraction from baseline through year one [ Time Frame: one year ]
    Manifest refraction, both eyes


Secondary Outcome Measures :
  1. Change in uncorrected visual acuity from baseline through year one [ Time Frame: one year ]
    Vision testing without correction, both eyes using Snellen Eye chart

  2. Change in best corrected visual acuity from baseline through year one [ Time Frame: one year ]
    Vision testing with correction, both eyes using Snellen Eye chart



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122535


Contacts
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Contact: Mark D Mifflin, MD 801-213-3447 Mark.Mifflin@hsc.utah.edu

Locations
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United States, Utah
University of Utah John A. Moran Eye Center - Midvalley Location Recruiting
Murray, Utah, United States, 84107
Contact: Mark Mifflin, MD    801-213-3447    Mark.Mifflin@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Mark D Mifflin, MD University of Utah Moran Eye Center
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Responsible Party: Mark Mifflin, Clinical Professor, Ophthalmology/Visual Sciences, University of Utah
ClinicalTrials.gov Identifier: NCT03122535    
Other Study ID Numbers: IRB 74858
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mark Mifflin, University of Utah:
Femtosecond LASIK (FS--LASIK)
Visual acuity
Refractive errors
Side-cut angles
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries