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

Last updated: November 26, 2024
Sponsor: Suphi Taneri
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Myopia

Treatment

Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)

Clinical Study ID

NCT04110067
SMILE > 7.75D
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adults

  • myopia more than -7.75 D

  • refractive stability more than 1 year

Exclusion

Exclusion Criteria:

  • corneal irregular astigmatism

  • ectatic conditions

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)
Phase:
Study Start date:
January 01, 2016
Estimated Completion Date:
November 30, 2029

Connect with a study center

  • Center for Refractive Surgery

    Münster, NRW 48145
    Germany

    Active - Recruiting

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