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

Alcon

Status: Terminated

Conditions: Myopia; Astigmatism

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02987660

RFL605-P001

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

LASIK with EX500

Experimental group

Description:

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

Treatment:

Device: WaveLight EX500 Excimer Laser System

Procedure: Topography Guided LASIK

SMILE with VisuMax

Active Comparator group

Description:

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

Treatment:

Procedure: Small Incision Lenticular Extraction

Device: VisuMax Surgical Laser