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 6, 2021
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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 |
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 : | December 31, 2021 |
Estimated Study Completion Date : | June 30, 2022 |

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 |
- 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
- 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
- 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
- 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 |
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.

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
Contact: Mark Mifflin, MD | 801-585-3937 | mark.mifflin@hsc.utah.edu | |
Contact: Myrna Church | 801-585-3937 | Myrna.Church@hsc.utah.edu |
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 |
Principal Investigator: | Mark Mifflin, MD | University of Utah Moran Eye Center |
Responsible Party: | Mark Mifflin, Professor, Ophthalmology/Visual Sciences, University of Utah |
ClinicalTrials.gov Identifier: | NCT03075176 |
Other Study ID Numbers: |
IRB # 95434 |
First Posted: | March 9, 2017 Key Record Dates |
Last Update Posted: | May 6, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Photorefractive keratectomy Laser-assisted in situ keratomileusis |
Myopia Refractive Errors Eye Diseases |