NCT07036835

Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

Clinical Investigation of the WaveLight® Ultraviolet Femtosecond Laser for Corneal Flap Creation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see how safe the WaveLight Ultraviolet Femtosecond Laser, Model 1026 (UV fs-Laser), is for creating corneal flaps during laser-assisted in situ keratomileusis (LASIK) surgery. This study will be conducted in Australia.

Detailed description

Subjects who qualify to participate will have both eyes treated. Each subject will be randomly assigned to 1 of 2 topical anesthetics (numbing eye drops) and each eye will be randomly assigned to either the UV fs-Laser or the WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser). Subjects will attend a total of 6 scheduled study visits, including a preoperative Screening Visit (Day -45 to -1), a Surgery Visit (Day 0), and 4 postoperative visits at Day 1, Week 1, Month 1, and Month 3/exit, for a total individual duration of participation of approximately 4 months.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
PROCEDURE	LASIK Surgery	Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
DEVICE	UV fs-Laser	WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
DEVICE	IR fs-Laser	WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
DEVICE	Anesthetic 1 eye drops	Topical anesthetic used to numb the surface of the eye
DEVICE	Anesthetic 2 eye drops	Topical anesthetic used to numb the surface of the eye

Timeline

• Start date: 2025-08-27
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-06-25
• Last updated: 2026-04-13

Locations

1 site across 1 country: Australia