Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax

Study Overview
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Brief Summary
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The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.

Official Title
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Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Procedure: Topography Guided LASIK
* Procedure: Small Incision Lenticular Extraction
* Device: WaveLight EX500 Excimer Laser System
* Device: VisuMax Surgical Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects in Singapore must be 21 years of age or older and subjects in Korea must be upon completion of 19 years of age or older due to local regulations; Able to comprehend and sign an informed consent form; Willing and able to complete all postoperative visits; Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism. Intended treatment targeted for emmetropia; Preoperative best-corrected visual acuity (BCVA) of 0 logMAR or better; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant or lactating, current or planned, during the course of the study; Dry eye; Corneal disease; Diagnosis of advanced glaucoma; Uncontrolled diabetes; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LASIK with EX500<br>Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery | Procedure: Topography Guided LASIK<br>* Corneal surgery for refractive error correction<br>Device: WaveLight EX500 Excimer Laser System<br>* As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.<br>|
| Active Comparator: SMILE with VisuMax<br>Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery | Procedure: Small Incision Lenticular Extraction<br>* Refractive surgical procedure for the correction of myopia with or without astigmatism<br>* Other names: SMILE;Device: VisuMax Surgical Laser<br>* As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months | Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Manifest Refraction Cylinder at 3 Months | Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed. | Month 3 | 
| Mean Uncorrected Visual Acuity (UCVA) at 3 Months | Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed. | Month 3 |