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

Last updated: December 20, 2024
Sponsor: Alcon Research
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Treatment

UV fs-Laser

IR fs-Laser

LASIK

Clinical Study ID

NCT06021353
RFO268-E005
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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.

Exclusion

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

Total Participants: 47
Treatment Group(s): 3
Primary Treatment: UV fs-Laser
Phase:
Study Start date:
October 20, 2023
Estimated Completion Date:
December 12, 2024

Study 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.

Connect with a study center

  • Personaleyes

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Laservision.gr Institute

    Athens, 11521
    Greece

    Site Not Available

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