Clinical Results of Small Incision Lenticule Extraction (... | NCT04110067

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

NCT04110067

Sponsor

Suphi Taneri

Status

Recruiting

Last Update Posted

Nov 29, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Myopia
High Myopia

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Nov 2029Estimated

Completion Date

Nov 2029Estimated

First Submitted Date

Sep 26, 2019

First Submission Date that Met QC Criteria

Sep 30, 2019

First Posted Date

Oct 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2024

Last Update Posted Date

Nov 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)	Other	Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

corneal irregular astigmatism
ectatic conditions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Suphi Taneri, MD	Contact	+492519877890		taneri@refraktives-zentrum.de
Anika Förster, M.Sc.	Contact	+492519877890		foerster@refraktives-zentrum.de

Overall Officials

Name	Affiliation	Role
Suphi Taneri, MD	Center for Refractive Surgery Muenster	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Refractive Surgery	Recruiting	Münster	North Rhine-Westphalia	48145	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

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