CClinicalTrials.gg
RecruitingNCT04110067Updated Nov 29, 2024

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

An observational study in Myopia and High Myopia, sponsored by Suphi Taneri. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Suphi Taneri · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

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
02

Conditions studied

  • Myopia
  • High Myopia

Browse trials for

Keywords

  • Myopia
  • Refractive Surgery
  • Small Incision Lenticule Extraction
  • SMILE
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 150 across 173 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Suphi Taneri is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • corneal irregular astigmatism
  • ectatic conditions
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
5,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • OtherSmall 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

    Also known as: RelaxSmile

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04110067
Lead sponsor
Suphi Taneri
Responsible party
Suphi Taneri (Director, St. Franziskus Hospital) — Sponsor-investigator
First posted
Oct 1, 2019
Start date
Jan 2016
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Nov 29, 2024

Study contacts

Suphi Taneri, MD
Contact
taneri@refraktives-zentrum.de
+492519877890
Anika Förster, M.Sc.
Contact
foerster@refraktives-zentrum.de
+492519877890
Suphi Taneri, MD
study chair · Center for Refractive Surgery Muenster

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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