PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-09

Study Completion Date

2023-03-25

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Myopia Astigmatism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SMILE

Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No