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

ConditionsMyopiaHigh Myopia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSuphi Taneri

About this trial

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

This trial accepts healthy volunteers

Qualifiers

adults

myopia more than -7.75 D

refractive stability more than 1 year

Disqualifiers

corneal irregular astigmatism

ectatic conditions

Trial population

Adult patients with myopia more than -7.75 D seeking refractive surgery

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: 11 intervention

Trial outcomes

Primary outcomes

1

Subjective Distance Refraction

Subjective Refraction

Time frame
1 year
2

Distance Visual Acuity

Visual Acuity sine and cum correctione

Time frame
1 year

Secondary outcomes

1

Tectonic stability as assessed by Pentacam

Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography

Time frame
1 year
2

Epithelial thickness map in Optical coherence tomography

Change of Thickness of epithelium pre and post surgery

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suphi Taneri

Lead sponsor

St. Franziskus Hospital

Sponsor institution

Source ClinicalTrials.gov
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