NCT04884672

PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 237 (actual)
• Sponsor: Carl Zeiss Meditec AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	SMILE	Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism

Timeline

• Start date: 2021-07-09
• Primary completion: 2023-03-25
• Completion: 2023-03-25
• First posted: 2021-05-13
• Last updated: 2023-10-23

Locations

5 sites across 4 countries: Denmark, Germany, Hong Kong, India