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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02987660
• Other study ID #: RFL605-P001
• Status: Terminated
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: July 26, 2017

Study information

• Verified date: July 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: July 26, 2017
• Est. primary completion date: July 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Procedure:
• Topography Guided LASIK
Corneal surgery for refractive error correction
• Small Incision Lenticular Extraction
Refractive surgical procedure for the correction of myopia with or without astigmatism

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.
• VisuMax Surgical Laser
As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.

Locations

Country	Name	City	State
France	Alcon Investigative Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Alcon, a Novartis Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Results from the Novartis Clinical Trial Results Website