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

Not Applicable

Terminated

Interventions: Procedure: Topography Guided LASIK
Procedure: Small Incision Lenticular Extraction
Device: WaveLight EX500 Excimer Laser System
Device: VisuMax Surgical Laser

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
LASIK with EX500	Topography Guided LASIK	Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
LASIK with EX500	WaveLight EX500 Excimer Laser System	Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
SMILE with VisuMax	Small Incision Lenticular Extraction	Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
SMILE with VisuMax	VisuMax Surgical Laser	Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months	Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Mean Manifest Refraction Cylinder at 3 Months	Month 3	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.
Mean Uncorrected Visual Acuity (UCVA) at 3 Months	Month 3	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.