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

Primary Purpose

Myopia, Astigmatism

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Topography Guided LASIK
Small Incision Lenticular Extraction
WaveLight EX500 Excimer Laser System
VisuMax Surgical Laser
Sponsored by
Alcon, a Novartis Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LASIK with EX500

SMILE with VisuMax

Arm Description

Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery

Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 7, 2016
Last Updated
July 9, 2018
Sponsor
Alcon, a Novartis Company
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1. Study Identification

Unique Protocol Identification Number
NCT02987660
Brief Title
Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax
Official Title
Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
management decision; non patient safety related reason
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
July 26, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon, a Novartis Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LASIK with EX500
Arm Type
Experimental
Arm Description
Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
Arm Title
SMILE with VisuMax
Arm Type
Active Comparator
Arm Description
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
Intervention Type
Procedure
Intervention Name(s)
Topography Guided LASIK
Intervention Description
Corneal surgery for refractive error correction
Intervention Type
Procedure
Intervention Name(s)
Small Incision Lenticular Extraction
Other Intervention Name(s)
SMILE
Intervention Description
Refractive surgical procedure for the correction of myopia with or without astigmatism
Intervention Type
Device
Intervention Name(s)
WaveLight EX500 Excimer Laser System
Intervention Description
As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.
Intervention Type
Device
Intervention Name(s)
VisuMax Surgical Laser
Intervention Description
As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.
Primary Outcome Measure Information:
Title
Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months
Description
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 Outcome Measure Information:
Title
Mean Manifest Refraction Cylinder at 3 Months
Description
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
Title
Mean Uncorrected Visual Acuity (UCVA) at 3 Months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon, A Novartis Division
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Paris
ZIP/Postal Code
75008
Country
France

12. IPD Sharing Statement

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

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