Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena).
- Who it may be relevant to
- Registry conditions: Myopia, High Myopia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- 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
Primary outcome measures
- Subjective Distance Refraction [Time frame: 1 year]
- Distance Visual Acuity [Time frame: 1 year]
Secondary outcome measures (2)
- Tectonic stability as assessed by Pentacam [Time frame: 1 year]
- Epithelial thickness map in Optical coherence tomography [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- adults
- myopia more than -7.75 D
- refractive stability more than 1 year
Exclusion criteria
- corneal irregular astigmatism
- ectatic conditions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Germany · 1 center
- Center for Refractive Surgery — Münster
Identifiers
NCT: NCT04110067 · SMILE > 7.75D