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

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 Overview

• Status: Terminated
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Procedure: Topography Guided LASIK; Device: WaveLight EX500 Excimer Laser System; Procedure: Small Incision Lenticular Extraction; Device: VisuMax Surgical Laser

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75008
    • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company
• Investigators: Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): July 26, 2017
• Study Completion (Actual): July 26, 2017

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: RFL605-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No