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NCT04110067 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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