Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

Alcon

Status: Enrolling

Conditions: Refractive Errors

Treatments: Device: Anesthetic 1 eye drops; Device: UV fs-Laser; Device: IR fs-Laser; Procedure: LASIK Surgery; Device: Anesthetic 2 eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT07036835

RFO268-C009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Eligible for LASIK treatment;
• Myopia as specified in the protocol;
• Uncorrected distance visual acuity of greater than or equal to 0.30 logMAR;
• Best corrected distance visual acuity of less than or equal to 0.10 logMAR;
• Presence of clear natural lens (non-cataractous eye);
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• An active implanted device for which laser use may be a contraindication;
• Previous ocular surgery;
• Ocular conditions that may affect subject safety or impact study outcomes;
• Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study;
• Current use of medications with known ocular side effects and photosensitivity;
• 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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174 participants in 4 patient groups

UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left

Other group

Description:

LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops

Treatment:

Device: IR fs-Laser

Procedure: LASIK Surgery

Device: UV fs-Laser

Device: Anesthetic 1 eye drops

UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right

Other group

Description:

LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops

Treatment:

Device: IR fs-Laser

Procedure: LASIK Surgery

Device: UV fs-Laser

Device: Anesthetic 1 eye drops

UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left

Other group

Description:

LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops

Treatment:

Device: Anesthetic 2 eye drops

Device: IR fs-Laser

Procedure: LASIK Surgery

Device: UV fs-Laser

UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right

Other group

Description:

LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops

Treatment:

Device: Anesthetic 2 eye drops

Device: IR fs-Laser

Procedure: LASIK Surgery

Device: UV fs-Laser