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

Sponsor
Suphi Taneri (Other)
Overall Status
Recruiting
CT.gov ID
NCT04110067
Collaborator
(none)
5,000
1
166
30.1

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2029
Anticipated Study Completion Date :
Nov 1, 2029

Arms and Interventions

Arm Intervention/Treatment
1

SMILE - Correction of eyes with myopia of more than -7.75 D

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
Other Names:
  • RelaxSmile
  • Outcome Measures

    Primary Outcome Measures

    1. Subjective Distance Refraction [1 year]

      Subjective Refraction

    2. Distance Visual Acuity [1 year]

      Visual Acuity sine and cum correctione

    Secondary Outcome Measures

    1. Tectonic stability as assessed by Pentacam [1 year]

      Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography

    2. Epithelial thickness map in Optical coherence tomography [1 year]

      Change of Thickness of epithelium pre and post surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • adults

    • myopia more than -7.75 D

    • refractive stability more than 1 year

    Exclusion Criteria:
    • corneal irregular astigmatism

    • ectatic conditions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Refractive Surgery Münster NRW Germany 48145

    Sponsors and Collaborators

    • Suphi Taneri

    Investigators

    • Study Chair: Suphi Taneri, MD, Center for Refractive Surgery Muenster

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suphi Taneri, Director, St. Franziskus Hospital
    ClinicalTrials.gov Identifier:
    NCT04110067
    Other Study ID Numbers:
    • SMILE > 7.75D
    First Posted:
    Oct 1, 2019
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Keywords provided by Suphi Taneri, Director, St. Franziskus Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2022