International Multicenter Study on SMILE Surgery

NCT02844556 | Unknown DMC

• 1 other identifier: Tianjin EH-SMILE
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SMILE surgery; FS-LASIK surgery; multicenter

Outcome Measures

Primary Outcomes (1)

• corrected visual acuity

  change from baseline with EDTRS chart at 6 months

Secondary Outcomes (11)

• uncorrected visual acuity

  change from baseline with EDTRS chart at 6 months

• spherical diopter

  change from baseline with manifest refraction at 6 months

• cylindrical dioptor

  change from baseline with manifest refraction at 6 months

• central corneal thickness

  change from baseline with the Pentacam system at 6 months

• corneal curvature assessed by the Pentacam system

  change from baseline with mean Pentacam keratometry at 6 months

Study Arms (2)

SMILE surgery

OTHER

Small incision lenticule extraction (SMILE) has become a novel and effective method for the correction of myopia and myopic astigmatism. It is a micro-invasive and flapless refractive procedure that has been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.

Procedure: SMILE surgery

FS-LASIK surgery

OTHER

FS-LASIK surgery is femtosecond laser assisted- conventional refractive surgery and has also 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

Interventions

SMILE surgery PROCEDURE

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.

SMILE surgery

FS-LASIK surgery OTHER

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.

FS-LASIK surgery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
• at baseline, be within the age range of 18 to 45 years old inclusive
• normal corneal morphology with no corneal nebula or corneal macula, the range of preoperative K2 (the steep curvature of the 3mm area at the center of cornea) from 38.0 to 47.0 diopter
• manifest spherical equivalent of -1.0 to -10.0 diopters (D)
• cylindrical diopter no more than -5.0D
• refractive diopter maintained stable for more than2 years
• preoperative BCVA≥0.8, and the scotopic pupil diameter≥5.0mm when measured by WASCA analyzer (Carl Zeiss Meditec AG)
• picked off soft contact lens for more than 2 weeks
• picked off RGP for more than 1 month
• preoperative corneal central thickness measured by Pentacam \>500μm, non-contact IOP\<21mmHg
• be willing to comply with the clinical trial visit schedule as directed by the investigator.

You may not qualify if:

• any corneal diseases, corneal operations, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
• corneal macula and obvious pannus; current enrolment in another clinical trial/research project.

Sponsors & Collaborators

• Tianjin Eye Hospital: lead
• Nethradhama Superspeciality Eye Hospital: collaborator
• Alexandria University: collaborator
• Belgian Ocular Laser Centre: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Jinan Mingshui Eye Hospital: collaborator

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

RECRUITING

Related Publications (5)

• Wei S, Wang Y. Comparison of corneal sensitivity between FS-LASIK and femtosecond lenticule extraction (ReLEx flex) or small-incision lenticule extraction (ReLEx smile) for myopic eyes. Graefes Arch Clin Exp Ophthalmol. 2013 Jun;251(6):1645-54. doi: 10.1007/s00417-013-2272-0. Epub 2013 Feb 7.

  PMID: 23389552 BACKGROUND

• Wang Y, Bao XL, Tang X, Zuo T, Geng WL, Jin Y. [Clinical study of femtosecond laser corneal small incision lenticule extraction for correction of myopia and myopic astigmatism]. Zhonghua Yan Ke Za Zhi. 2013 Apr;49(4):292-8. Chinese.

  PMID: 23900086 BACKGROUND

• Wu D, Wang Y, Zhang L, Wei S, Tang X. Corneal biomechanical effects: small-incision lenticule extraction versus femtosecond laser-assisted laser in situ keratomileusis. J Cataract Refract Surg. 2014 Jun;40(6):954-62. doi: 10.1016/j.jcrs.2013.07.056. Epub 2014 Apr 18.

  PMID: 24751146 BACKGROUND

• Li X, Wang Y, Dou R. Aberration compensation between anterior and posterior corneal surfaces after Small incision lenticule extraction and Femtosecond laser-assisted laser in-situ keratomileusis. Ophthalmic Physiol Opt. 2015 Sep;35(5):540-51. doi: 10.1111/opo.12226. Epub 2015 Jun 18.

  PMID: 26087672 BACKGROUND

• Zhang J, Wang Y, Wu W, Xu L, Li X, Dou R. Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up. BMC Ophthalmol. 2015 Jan 24;15:8. doi: 10.1186/1471-2415-15-8.

  PMID: 25618419 BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Yan Wang, director

  Tianjin Eye Hospital

  STUDY DIRECTOR

• Sri Ganesh, professor

  Nethradhama Superspeciality Eye Hospital

  PRINCIPAL INVESTIGATOR

• Bernard Heintz, professor

  Belgian Ocular Laser Centre

  PRINCIPAL INVESTIGATOR

• Osama Ibrahim, professor

  Cornea Center, Alexandria University

  PRINCIPAL INVESTIGATOR

• Keming Yu, professor

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

  PRINCIPAL INVESTIGATOR

• Yulin Lei, professor

  Jinan Mingshui Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang, director

CONTACT

wangyan7143@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 26, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)