PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

Carl Zeiss Meditec

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: SMILE

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04884672

V1902PM

Details and patient eligibility

About

The primary objective of this PMCF investigation is to systematically collect safety and effectiveness data with the VISUMAX 800 laser in clinical daily routine SMILE use for the purpose of post market surveillance.

Full description

The present PMCF study is a prospective, non-randomized, international multi-center study without control group including patients with myopia or myopia combined with astigmatism undergoing SMILE with the VISUMAX 800 femtosecond laser in daily routine use.

In this PMCF study, at maximum 474 eyes of consecutive subjects will be consented, enrolled, treated and followed up to 6 months postoperatively at 4 to 5 sites. The treatments, which will be done bilateral, shall be equally distributed between the sites as far as possible.

The subjects will be 18 years of age or older, who suffer from myopia of up to -10 D with or without astigmatism of up to 5 D, and are suitable for SMILE treatments, fulfil all inclusion criteria and not fulfil any of the exclusion criteria.

The expected duration of the is 16 months (site initiation to closeout visit).

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Myopia up to -10 D with and without astigmatism up to 5 D
• Age of 18 years or older
• Pre-operative CDVA of 20/25 or better in each eye
• Patient shall be willing to comply with all follow-up visits and the respective examinations
• Patients should be able to understand the patient information and willing to sign an informed consent.
• Contact lens wearers must stop wearing their contact lenses at least 2 weeks before baseline measurements in case of hard contact lenses and 2 days before baseline measurements in case of soft contact lenses

Exclusion criteria

• No monovision treatments (target sphere may not be more negative than -0.25 D)
• The patient may not participate in other ophthalmologic studies except in VEMOS study at site Aarhus.
• Any impaired person (minors, pregnant or breast-feeding women or persons incapable of giving consent) are definitely excluded from the study.
• The patients presenting at least one of the contraindications stated in User Manual of the VISUMAX 800 option ReLEx SMILE must not be included in this clinical investigation