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

Alcon

Status: Active, not recruiting

Conditions: Refractive Errors

Treatments: Device: UV fs-Laser; Device: IR fs-Laser; Procedure: LASIK

Study type: Interventional

Funder types: Industry

Identifiers

NCT06021353

RFO268-E005

Details and patient eligibility

About

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).

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

UV fs-Laser

Other group

Description:

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

Treatment:

Procedure: LASIK

Device: UV fs-Laser

IR fs-Laser

Other group

Description:

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

Treatment:

Procedure: LASIK

Device: IR fs-Laser