Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy

Study Overview
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Brief Summary
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This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Each participant will receive wavefront optimized correction in one eye and topography-guided correction in the other.

Detailed Description
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Participants will have an in depth discussion with our refractive surgery coordinator regarding refractive surgery. Patients will choose LASIK or Photorefractive Keratectomy surgery based on our standard pre-operative discussion that is provided to all patients. As is standard for laser refractive candidates, the advantages and disadvantages of LASIK and Photorefractive Keratectomy compared to the other refractive surgical options will be discussed. Following patient selection of their preferred type of refractive procedure they will be randomized as discussed below, and only patients who elect for LASIK or Photorefractive Keratectomy will be included in our study. Prior to surgery, one eye from each patient will be randomly assigned to receive either Wavefront optimized or Topography Guided treatment. Each patient in the study will have a fellow eye enrolled in the other treatment group. Patients will either receive LASIK treatment or Photorefractive Keratectomy treatment in both eyes but the eyes will be randomized to topography guided or wavefront optimized forms of treatment.

Official Title
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Outcomes of Topography-guided LASIK and Photorefractive Keratectomy Compared to Wavefront Optimized LASIK and Photorefractive Keratectomy

Conditions
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Surgery, Myopia

Intervention / Treatment
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* Device: Wavefront optimized LASIK
* Device: Wavefront optimized Photorefractive Keratectomy
* Device: Topography-guided LASIK
* Device: Topography-guided Photorefractive Keratectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wavefront optimized LASIK<br>Participants who chose to have LASIK surgery were assigned to have Wavefront optimized LASIK in one eye and Topography-guided LASIK in the other eye (randomly chosen). | Device: Wavefront optimized LASIK<br>* Wavefront optimized laser vision correction<br>Device: Topography-guided LASIK<br>* Topography-guided laser vision correction<br>|
| Active Comparator: Wavefront optimized Photorefractive Keratectomy<br>Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Wavefront optimized Photorefractive Keratectomy in one eye and Topography-guided Photorefractive Keratectomy in the other eye (randomly chosen). | Device: Wavefront optimized Photorefractive Keratectomy<br>* Wavefront optimized laser vision correction<br>Device: Topography-guided Photorefractive Keratectomy<br>* Topography-guided laser vision correction<br>|
| Active Comparator: Topography-guided LASIK<br>Participants who chose to have LASIK surgery were assigned to have Topography-guided LASIK in one eye and Wavefront optimized LASIK in the other eye (randomly chosen). | Device: Wavefront optimized LASIK<br>* Wavefront optimized laser vision correction<br>Device: Topography-guided LASIK<br>* Topography-guided laser vision correction<br>|
| Active Comparator: Topography-guided Photorefractive Keratectomy<br>Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Topography-guided Photorefractive Keratectomy in one eye and Wavefront optimized Photorefractive Keratectomy in the other eye (randomly chosen). | Device: Wavefront optimized Photorefractive Keratectomy<br>* Wavefront optimized laser vision correction<br>Device: Topography-guided Photorefractive Keratectomy<br>* Topography-guided laser vision correction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Uncorrected Visual Acuity From Baseline to Month 12 | Uncorrected visual acuity will be tested pre-operatively through month 12 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Contrast Sensitivity From Baseline to Month 3 | Contrast sensitivity will be tested pre-operatively and 3 months post-operatively | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser-assisted in situ keratomileusis, Photorefractive keratectomy