Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia

Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism.

It involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. This enables rapid visual recovery with very little discomfort to the patient.

This observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 D.

It is to

• gather long-term results and refractive stability
• detect rare complications or side-effects
• evaluate the efficacy in a large number of patients

Study Overview

• Status: Recruiting
• Conditions: Myopia; High Myopia
• Intervention / Treatment: Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Suphi Taneri, MD; Phone Number: +492519877890; Email: taneri@refraktives-zentrum.de
• Study Contact Backup: Name: Anika Rost, M.Sc.; Phone Number: +492519877890; Email: rost@refraktives-zentrum.de

Study Locations

• Germany
  • NRW
    • Münster, NRW, Germany, 48145
      • Recruiting
      • Center for Refractive Surgery
      • Contact: Suphi Taneri, MD; Phone Number: +492519877890; Email: taneri@refraktives-zentrum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with myopia more than -7.75 D seeking refractive surgery

Description

Inclusion Criteria:

• adults
• myopia more than -7.75 D
• refractive stability more than 1 year

Exclusion Criteria:

• corneal irregular astigmatism
• ectatic conditions

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; SMILE - Correction of eyes with myopia of more than -7.75 D	Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena); Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser; Other Names: RelaxSmile

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Distance Refraction	Subjective Refraction	1 year
Distance Visual Acuity	Visual Acuity sine and cum correctione	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tectonic stability as assessed by Pentacam	Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography	1 year
Epithelial thickness map in Optical coherence tomography	Change of Thickness of epithelium pre and post surgery	1 year

Collaborators and Investigators

• Sponsor: Suphi Taneri
• Investigators: Study Chair: Suphi Taneri, MD, Center for Refractive Surgery Muenster

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: SMILE; Small Incision Lenticule Extraction; Myopia; Refractive Surgery
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SMILE > 7.75D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No