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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2017-07-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Myopia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LASIK with EX500

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

Group Type EXPERIMENTAL

Topography Guided LASIK

Intervention Type PROCEDURE

Corneal surgery for refractive error correction

WaveLight EX500 Excimer Laser System

Intervention Type DEVICE

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

SMILE with VisuMax

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

Group Type ACTIVE_COMPARATOR

Small Incision Lenticular Extraction

Intervention Type PROCEDURE

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

VisuMax Surgical Laser

Intervention Type DEVICE

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

Interventions

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Topography Guided LASIK

Corneal surgery for refractive error correction

Intervention Type PROCEDURE

Small Incision Lenticular Extraction

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

Intervention Type PROCEDURE

WaveLight EX500 Excimer Laser System

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

Intervention Type DEVICE

VisuMax Surgical Laser

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

Intervention Type DEVICE

Other Intervention Names

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SMILE

Eligibility Criteria

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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;

Exclusion Criteria

* Pregnant or lactating, current or planned, during the course of the study;
* Dry eye;
* Corneal disease;
* Diagnosis of advanced glaucoma;
* Uncontrolled diabetes;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No