NCT06021353

Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation

Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).

Detailed description

Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	UV fs-Laser	Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
DEVICE	IR fs-Laser	Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
PROCEDURE	LASIK	Laser-assisted in situ keratomileusis (LASIK) surgery

Timeline

• Start date: 2023-10-20
• Primary completion: 2024-12-12
• Completion: 2024-12-12
• First posted: 2023-09-01
• Last updated: 2024-12-27

Locations

1 site across 1 country: Australia