Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2022-10-19
2024-09-24
Brief Summary
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Detailed Description
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Three FDA-approved laser devices are being used for the study.
Two excimer lasers are being used for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.
One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway.
All three lasers are being used according to their approved indications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Wavefront-guided LASIK
Wavefront-guided LASIK for myopia and myopic astigmatism
Wavefront-guided LASIK
Topography-guided utilizes topography mapping to perform the ablation
Topography-guided LASIK
Topography-guided LASIK for myopia and myopic astigmatism
Wavefront-guided
Wavefront-guided utilizes aberrometry to perform the ablation
Interventions
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Wavefront-guided LASIK
Topography-guided utilizes topography mapping to perform the ablation
Wavefront-guided
Wavefront-guided utilizes aberrometry to perform the ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with less than or equal to 3.00 diopters of astigmatism.
Exclusion Criteria
* Subjects with excessively thin corneas.
* Subjects with topographic evidence of keratoconus.
* Subjects with ectactic eye disorders.
* Subjects with autoimmune diseases.
* Subjects who are pregnant or nursing.
* Subjects must have similar levels of nearsightedness in each eye. They cannot be more than 1.5 diopter of difference between eyes.
* Subjects with more than 3.00 diopters of astigmatism
* Subjects must have similar levels of astigmatism in each eye. They cannot have more than 1.00 diopters of difference between eyes.
22 Years
59 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Edward E. Manche
Professor of Ophthalmology
Principal Investigators
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Edward E Manche, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Palo Alto, California, United States
Countries
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References
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Lu L, Manche E. Prospective, randomized, contralateral eye comparison of wavefront-guided and topography-guided LASIK. J Cataract Refract Surg. 2025 Oct 1;51(10):889-894. doi: 10.1097/j.jcrs.0000000000001703.
Other Identifiers
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63961
Identifier Type: -
Identifier Source: org_study_id
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