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

NCT ID: NCT04110067

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2029-11-30

Brief Summary

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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

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Conditions

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Myopia High Myopia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

SMILE - Correction of eyes with myopia of more than -7.75 D

Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)

Intervention Type OTHER

Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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RelaxSmile

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* corneal irregular astigmatism
* ectatic conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Suphi Taneri

OTHER

Sponsor Role lead

Responsible Party

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Suphi Taneri

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Suphi Taneri, MD

Role: STUDY_CHAIR

Center for Refractive Surgery Muenster

Locations

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Center for Refractive Surgery

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Suphi Taneri, MD

Role: CONTACT

+492519877890

Anika Förster, M.Sc.

Role: CONTACT

+492519877890

Facility Contacts

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Suphi Taneri, MD

Role: primary

+492519877890

Other Identifiers

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SMILE > 7.75D

Identifier Type: -

Identifier Source: org_study_id