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

Recruiting

• Conditions: High Myopia; Myopia
• Interventions: Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)

• Registration Number: NCT04110067
• Lead Sponsor: Suphi Taneri

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Primary Completion: 2029-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• corneal irregular astigmatism
• ectatic conditions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)	SMILE - Correction of eyes with myopia of more than -7.75 D

Primary Outcome Measures

Name	Time	Method
Subjective Distance Refraction	1 year	Subjective Refraction
Distance Visual Acuity	1 year	Visual Acuity sine and cum correctione

Secondary Outcome Measures

Name	Time	Method
Epithelial thickness map in Optical coherence tomography	1 year	Change of Thickness of epithelium pre and post surgery
Tectonic stability as assessed by Pentacam	1 year	Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography

Trial Locations

Locations (1)

Center for Refractive Surgery; 🇩🇪 Münster, NRW, Germany