Wavefront-guided vs. Topography-guided LASIK

Study Overview
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Brief Summary
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The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.

Detailed Description
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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.

Official Title
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A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery

Conditions
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Myopia

Intervention / Treatment
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* Procedure: Wavefront-guided LASIK
* Procedure: Wavefront-guided


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants contribute one eye to each study arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wavefront-guided LASIK<br>Wavefront-guided LASIK for myopia and myopic astigmatism | Procedure: Wavefront-guided LASIK<br>* Topography-guided utilizes topography mapping to perform the ablation<br>* Other names: Topography-guided LASIK;|
| Active Comparator: Topography-guided LASIK<br>Topography-guided LASIK for myopia and myopic astigmatism | Procedure: Wavefront-guided<br>* Wavefront-guided utilizes aberrometry to perform the ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of eyes achieving uncorrected visual acuity | 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 | 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 | Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected | One year | 
| Patient Quality of Vision | Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK | One year | 
| Change in corneal epithelial thickness | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wavefront-guided, topography-guided, LASIK