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

NCT04110067 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2024-11-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Suphi Taneri

    lead OTHER

Principal Investigators

  • Suphi Taneri, MD · Center for Refractive Surgery Muenster

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2029-11-30
Completion
2029-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110067 on ClinicalTrials.gov