NCT04110067

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Suphi Taneri · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Myopia
• High Myopia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2019-10-01
• Last updated: 2024-11-29

Locations

1 site across 1 country: Germany