NCT04794023

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Ziemer Ophthalmic Systems AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Corneal Ablation	Corneal ablation for the treatment of myopia with/without astigmatism following flap creation using femtosecond laser.

Timeline

• Start date: 2021-03-31
• Primary completion: 2022-05-01
• Completion: 2022-06-01
• First posted: 2021-03-11
• Last updated: 2021-11-18

Locations

1 site across 1 country: Switzerland