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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021353
• Other study ID #: RFO268-E005
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Good ocular health;

• Natural lens with no evidence of cataract;

• Eligible for LASIK;

• Stable refraction;

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Presence of dry eye;

• Contraindicated systemic disease or ocular conditions;

• Treatment with a contraindicated medication;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• UV fs-Laser
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
• 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

Locations

Country	Name	City	State
Australia	Personaleyes	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month	Corneal flap thickness will be measured using optical coherence tomography (OCT)	Month 1