Wavefront-guided vs. Topography-guided LASIK
A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94303
- Stanford University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria.
- Subjects ages 22 to 59with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters.
- Subjects with less than or equal to 3.00 diopters of astigmatism.
Exclusion criteria.
- Subjects under the age of 22 and over the age of 59
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Wavefront-guided LASIK
Wavefront-guided LASIK for myopia and myopic astigmatism
|
Topography-guided utilizes topography mapping to perform the ablation
Other Names:
|
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Active Comparator: Topography-guided LASIK
Topography-guided LASIK for myopia and myopic astigmatism
|
Wavefront-guided utilizes aberrometry to perform the ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of eyes achieving uncorrected visual acuity
Time Frame: One year
|
Percentage of eyes achieving an uncorrected visual acuity of 20/40, 20/25 ,20/20, 20/16, 20/12.5 and 20/10 at post-operative month twelve
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of eyes with a change in two or more lines of corrected visual acuity
Time Frame: One year
|
Percentage of eyes gaining or losing two or more lines of corrected visual acuity Percentage of eyes gaining or losing 2 or more lines of corrected distance visual acuity
|
One year
|
|
Predictability
Time Frame: One year
|
Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected
|
One year
|
|
Patient Quality of Vision
Time Frame: One year
|
Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK
|
One year
|
|
Change in corneal epithelial thickness
Time Frame: One year
|
We will be measuring the average change in central corneal epithelial thickness from preoperative to post-operative month12 in eyes undergoing Wavefront-guided LASIK and Topography-guided LASIK
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edward E Manche, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 63961
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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