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LASIK Surgery With a New Laser for the Treatment of Myopia Without Astigmatism — AQUARIUZ2020  

Myopia Clinical Trial

Official title:
A Combined First In Man And Pilot Study Investigating Visual And Refractive Outcomes In Lasik Surgery Using The Aquariuz Ablation Laser In Patients With Myopia, With Or Without Astigmatism

Clinical Trial Summary

The AQUARIUZ ablation laser is a solid-state laser and has been CE approved for corneal surgery since March 2020 for the treatment of short- and longsightedness with and without astigmatism. The aim of this study is to collect the first clinical data. Safety and performance are examined here. The treatment with AQUARIUZ is comparable to treatments with an excimer laser, with the difference that these are operated with gas. Solid-state lasers and excimer lasers use the same process for tissue ablation, with a small difference in wavelength. This difference manifests itself in the lower involvement of water in the ablation process with the result of a gentler and safer treatment. Similar to excimer lasers for corneal surgery, the AQAURIUZ system (Ziemer Ophthalmic Systems AG) is equipped with a fast eye tracker (eye tracking system) to correct eye movements during the treatment. The shape of the removed portion of the cornea has an aspherical profile corresponding to the state of the art. The primary objective is to assess the safety of use of the AQUARIUZ corneal ablation laser for LASIK procedures in myopia and myopia with astigmatism. The secondary objective is to compare the predicted visual and refractive outcomes of LASIK procedures using the AQUARIUZ Ablation with clinical data. The study is planned in 3 phases to mitigate the inherent risk of a first in man study and to allow for verification and confirmation of the system correction factor at an early stage.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04794023
Study type Interventional
Source Ziemer Ophthalmic Systems AG
Contact Valéry V Wittwer, Dr. med.
Phone +41 79 528 53 75
Email v.wittwer@icloud.com
Status Recruiting
Phase N/A
Start date March 31, 2021
Completion date June 2022
View Details
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