Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
1 other identifier
observational
5,000
1 country
1
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
- gather long-term results and refractive stability
- detect rare complications or side-effects
- evaluate the efficacy in a large number of patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
November 29, 2024
November 1, 2024
13.8 years
September 26, 2019
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Subjective Distance Refraction
Subjective Refraction
1 year
Distance Visual Acuity
Visual Acuity sine and cum correctione
1 year
Secondary Outcomes (2)
Tectonic stability as assessed by Pentacam
1 year
Epithelial thickness map in Optical coherence tomography
1 year
Study Arms (1)
1
SMILE - Correction of eyes with myopia of more than -7.75 D
Interventions
Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser
Eligibility Criteria
Adult patients with myopia more than -7.75 D seeking refractive surgery
You may qualify if:
- adults
- myopia more than -7.75 D
- refractive stability more than 1 year
You may not qualify if:
- corneal irregular astigmatism
- ectatic conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Suphi Tanerilead
Study Sites (1)
Center for Refractive Surgery
Münster, North Rhine-Westphalia, 48145, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Suphi Taneri, MD
Center for Refractive Surgery Muenster
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 26, 2019
First Posted
October 1, 2019
Study Start
January 1, 2016
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
November 29, 2024
Record last verified: 2024-11