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Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy

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ClinicalTrials.gov Identifier: NCT03075176
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Mifflin, University of Utah

Brief Summary:
This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Each participant will receive wavefront optimized correction in one eye and topography-guided correction in the other.

Condition or disease Intervention/treatment Phase
Surgery Myopia Device: Wavefront optimized LASIK Device: Wavefront optimized Photorefractive Keratectomy Device: Topography-guided LASIK Device: Topography-guided Photorefractive Keratectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.
Masking: Single (Participant)
Masking Description: Participants will be masked as to which type of surgery they receive in either eye.
Primary Purpose: Treatment
Official Title: Outcomes of Topography-guided LASIK and Photorefractive Keratectomy Compared to Wavefront Optimized LASIK and Photorefractive Keratectomy
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Wavefront optimized LASIK Device: Wavefront optimized LASIK
Wavefront optimized laser vision correction

Device: Topography-guided LASIK
Topography-guided laser vision correction

Active Comparator: Wavefront optimized Photorefractive Keratectomy Device: Wavefront optimized Photorefractive Keratectomy
Wavefront optimized laser vision correction

Device: Topography-guided Photorefractive Keratectomy
Topography-guided laser vision correction

Active Comparator: Topography-guided LASIK Device: Wavefront optimized LASIK
Wavefront optimized laser vision correction

Device: Topography-guided LASIK
Topography-guided laser vision correction

Active Comparator: Topography-guided Photorefractive Keratectomy Device: Wavefront optimized Photorefractive Keratectomy
Wavefront optimized laser vision correction

Device: Topography-guided Photorefractive Keratectomy
Topography-guided laser vision correction




Primary Outcome Measures :
  1. Change in uncorrected visual acuity from baseline to month 12 [ Time Frame: 12 months ]
    Uncorrected visual acuity will be tested pre-operatively through month 12


Secondary Outcome Measures :
  1. Change in contrast sensitivity from baseline to month 3 [ Time Frame: 3 months ]
    Contrast sensitivity will be tested pre-operatively and 3 months post-operatively


Other Outcome Measures:
  1. Change in degree of higher order aberrations from baseline to 3 months [ Time Frame: 3 months ]
    Aberrometry measurements will be taken pre-operatively and 3 months post surgery

  2. Change in quality of life score from baseline to 3 months [ Time Frame: 3 months ]
    The validated Quality of Life Impact of Refractive Correction survey will be administered pre-operatively and 3 months post surgery



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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:

  • All subjects who are deemed suitable candidates for laser refractive surgery after routine refractive surgery screening will be considered eligible for participation in this study.

Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy)

Exclusion Criteria:

  • Any patient who is not a suitable candidate for LASIK or PRK 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): NCT03075176


Contacts
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Contact: Christopher B Smith, MD 801-585-3937 christopherb.smith@hsc.utah.edu
Contact: Myrna Church 801-585-3937 Myrna.Church@hsc.utah.edu

Locations
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United States, Utah
Moran Eye Center - Midvalley Location Recruiting
Murray, Utah, United States, 84107
Contact: Mark Mifflin, MD    801-583-3447    Mark.Mifflin@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Mark Mifflin, MD University of Utah Moran Eye Center

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Responsible Party: Mark Mifflin, Professor, Ophthalmology/Visual Sciences, University of Utah
ClinicalTrials.gov Identifier: NCT03075176     History of Changes
Other Study ID Numbers: IRB # 95434
First Posted: March 9, 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mark Mifflin, University of Utah:
Photorefractive keratectomy
Laser-assisted in situ keratomileusis
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases