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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04110067

Enrollment

5000

Registered

2019-10-01

Start date

2016-01-31

Completion date

2029-11-30

Last updated

2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Myopia, Myopia

Keywords

Myopia, Refractive Surgery, Small Incision Lenticule Extraction, SMILE

Brief summary

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

Interventions

OTHERSmall 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

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* corneal irregular astigmatism * ectatic conditions

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Primary ContactSuphi Taneri, MD

taneri@refraktives-zentrum.de+492519877890

Backup ContactAnika Förster, M.Sc.

foerster@refraktives-zentrum.de+492519877890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026