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NCT06021353 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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