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NCT Number: NCT04110067

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

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

Recruiting

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Key information

Conditions

Myopia Eye Diseases High Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Refractive Surgery

Münster, North Rhine-Westphalia, 48145, Germany

Location status: Recruiting

Location contact

Suphi Taneri, MD

CONTACT

[email protected]

+492519877890

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults
  • myopia more than -7.75 D
  • refractive stability more than 1 year

Exclusion criteria

  • corneal irregular astigmatism
  • ectatic conditions

Treatment and study plan

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

Other

Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser

Other names: RelaxSmile

Primary outcomes

  1. Subjective Distance Refraction

    Time frame: 1 year

    Subjective Refraction

  2. Distance Visual Acuity

    Time frame: 1 year

    Visual Acuity sine and cum correctione

Secondary outcomes

  1. Tectonic stability as assessed by Pentacam

    Time frame: 1 year

    Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography

  2. Epithelial thickness map in Optical coherence tomography

    Time frame: 1 year

    Change of Thickness of epithelium pre and post surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Anika Förster, M.Sc.

CONTACT

[email protected]

+492519877890

Suphi Taneri, MD

CONTACT

[email protected]

+492519877890

Sponsors and collaborators

Lead sponsor

Suphi Taneri

Other

Registry information

Important dates

Study start
2016
Primary completion
2029
Study completion
2029
First posted
Oct 1, 2019
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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