International Multicenter Study on SMILE Surgery

Summary

The purpose of this study is to carry out an international multicenter trial to get more convincing and valuable results of the SMILE surgery and compare the outcomes between the SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis) surgery.

The investigators hope to investigate the differences between the SMILE and the FS-LASIK surgery comprehensively, including the comparison of visual acuity, refraction, the correction of cylindrical diopter, the high order aberrations, the corneal biomechanics, the corneal ectasia, the characteristics of the changes of central corneal thickness and the complications. To meet the demands of a multi center trial, all the examination equipments should be same in each center, and this will limit the variations within a study

Conditions

• Refractive Error

Interventions

PROCEDURE

SMILE surgery

SMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.

OTHER

FS-LASIK surgery

SMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.

Sponsors & Collaborators

• Nethradhama Superspeciality Eye Hospital

  collaborator OTHER

• Alexandria University

  collaborator OTHER

• Belgian Ocular Laser Centre

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Jinan Mingshui Eye Hospital

  collaborator OTHER

• Tianjin Eye Hospital

  lead OTHER

Principal Investigators

• Yan Wang, director · Tianjin Eye Hospital

• Sri Ganesh, professor · Nethradhama Superspeciality Eye Hospital

• Bernard Heintz, professor · Belgian Ocular Laser Centre

• Osama Ibrahim, professor · Cornea Center, Alexandria University

• Keming Yu, professor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Yulin Lei, professor · Jinan Mingshui Eye Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2019-09-30

Completion

2019-12-31

Countries

• China

Study Locations