Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 8:09 AM
Study NCT ID:
NCT04110067
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Sponsor:
Suphi Taneri
Organization:
Study Overview
Official Title:
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: