Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
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
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gather long-term results and refractive stability
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detect rare complications or side-effects
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evaluate the efficacy in a large number of patients
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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Outcome Measures
Primary Outcome Measures
- Subjective Distance Refraction [1 year]
Subjective Refraction
- Distance Visual Acuity [1 year]
Visual Acuity sine and cum correctione
Secondary Outcome Measures
- Tectonic stability as assessed by Pentacam [1 year]
Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography
- Epithelial thickness map in Optical coherence tomography [1 year]
Change of Thickness of epithelium pre and post surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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adults
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myopia more than -7.75 D
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refractive stability more than 1 year
Exclusion Criteria:
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corneal irregular astigmatism
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ectatic conditions
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- SMILE > 7.75D