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

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: UV fs-Laser; Device: IR fs-Laser; Procedure: LASIK

• Registration Number: NCT06021353
• Lead Sponsor: Alcon Research

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-01
• Study Start: 2023-10-20
• Status Verified: 2024-12
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IR fs-Laser	LASIK	First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery
UV fs-Laser	UV fs-Laser	First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery
UV fs-Laser	LASIK	First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery
IR fs-Laser	IR fs-Laser	First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery

Primary Outcome Measures

Name	Time	Method
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month	Month 1	Corneal flap thickness will be measured using optical coherence tomography (OCT)

Trial Locations

Locations (1)

Personaleyes; 🇦🇺 Sydney, New South Wales, Australia