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A Prospective Randomized Comparison of Wavefront-guided LASIK Surgery to Ray Tracing-Guided LASIK Surgery
We are enrolling participants aged 22 and older to have LASIK surgery in both eyes. We will perform wavefront-guided LASIK in one eye and ray tracing-guided LASIK in the fellow eye of each participant. We are trying to see if there are any differences in the efficacy between the two types of LASIK procedures.
We are comparing the outcomes of wavefront-guided LASIK (laser in-situ keratomileusis) and ray tracing-guided LASIK for nearsightedness with and without astigmatism. Wavefront aberrometry (a non-contact laser measuring device) is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system and calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism (a non-spherical shape). One eye will be treated with ray tracing-guided LASIK and the other eye treated with the wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling. We plan to enroll up to 70 near-sighted study participants to undergo treatment in this clinical research trial. The choice of which eye receives ray tracing-guided LASIK surgery and which eye receives wavefront-guided LASIK will be randomized (assigned at random) prior to enrollment. Participants scheduled to undergo LASIK for the correction of myopia (nearsightedness) will be screened for eligibility. Eligible participants will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, participants will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Re-treatments (a second operation on the same eye for residual nearsightedness, farsightedness and/or astigmatism) will not be allowed during the first twelve months of this study.. If a participant elects to undergo a re-treatment of the initial LASIK surgery prior to the 12-month post-operative visit, the data after the retreatment procedure will be excluded from the study analysis. The primary aim of the research is to compare outcomes between the two procedures. All of the procedures performed during the study are considered standard of care for LASIK surgeries.
Age
22 - 59 years
Sex
ALL
Healthy Volunteers
Yes
Byers Eye Institute at Stanford University School of Medicine
Palo Alto, California, United States
Start Date
January 20, 2026
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2027
Last Updated
January 22, 2026
70
ESTIMATED participants
LASIK
PROCEDURE
LASIK
PROCEDURE
Lead Sponsor
Stanford University
NCT07329777
NCT07323251
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05770661