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

November 26, 2024 updated by: Suphi Taneri

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patients with myopia more than -7.75 D seeking refractive surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • corneal irregular astigmatism
  • ectatic conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:
  • RelaxSmile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Distance Refraction
Time Frame: 1 year
Subjective Refraction
1 year
Distance Visual Acuity
Time Frame: 1 year
Visual Acuity sine and cum correctione
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suphi Taneri

Investigators

  • Study Chair: Suphi Taneri, MD, Center for Refractive Surgery Muenster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMILE > 7.75D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myopia

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe