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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110067
• Other study ID #: SMILE > 7.75D
• Status: Recruiting
• Start date: January 2016
• Est. completion date: November 2029

Study information

• Verified date: April 2024
• Source: St. Franziskus Hospital
• Contact: Suphi Taneri, MD
• Phone: +492519877890
• Email: taneri[@]refraktives-zentrum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: November 2029
• Est. primary completion date: November 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults

• myopia more than -7.75 D

• refractive stability more than 1 year

Exclusion Criteria:

• corneal irregular astigmatism

• ectatic conditions

Related Conditions & MeSH terms

• High Myopia
• Myopia

Intervention

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

Locations

Country	Name	City	State
Germany	Center for Refractive Surgery	Münster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Suphi Taneri

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Distance Refraction	Subjective Refraction	1 year
Primary	Distance Visual Acuity	Visual Acuity sine and cum correctione	1 year
Secondary	Tectonic stability as assessed by Pentacam	Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography	1 year
Secondary	Epithelial thickness map in Optical coherence tomography	Change of Thickness of epithelium pre and post surgery	1 year