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

Alcon, a Novartis Company21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia Astigmatism

Interventions

Topography Guided LASIKPROCEDURE

Corneal surgery for refractive error correction

Small Incision Lenticular ExtractionPROCEDURE

Refractive surgical procedure for the correction of myopia with or without astigmatism

WaveLight EX500 Excimer Laser SystemDEVICE

As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Alcon Investigative Site

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: Month 3

Secondary Outcomes

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.

Time frame: 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.

Time frame: Month 3

Data from ClinicalTrials.gov

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