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PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

Myopia Clinical Trial

Official title:
Post-Market Clinical Follow-up Study on SMILE Treatment of Myopia With and Without Astigmatism by VISUMAX 800

Clinical Trial Summary

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04884672
Study type Observational
Source Carl Zeiss Meditec AG
Contact
Status Completed
Phase
Start date July 9, 2021
Completion date March 25, 2023
View Details
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