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

Suphi Taneri

Status: Enrolling

Conditions: Myopia; High Myopia

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

Study type: Observational

Funder types: Other

Identifiers

NCT04110067

SMILE > 7.75D

Details and patient eligibility

About

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

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• corneal irregular astigmatism
• ectatic conditions

Trial design

5,000 participants in 1 patient group

1

Description:

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

Treatment:

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