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

RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 criteria

  • Presence of dry eye
  • Contraindicated systemic disease or ocular conditions
  • Treatment with a contraindicated medication
  • Other protocol-defined exclusion criteria may apply
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-10-20

    Primary completion: 2024-12-01

    Study completion finish: 2024-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT06021353

    Intervention or treatment

    DEVICE: UV fs-Laser

    DEVICE: IR fs-Laser

    PROCEDURE: LASIK

    Conditions

    • Refractive Errors

    Find a site

    Closest Location:

    Personaleyes

    Research sites nearby

    Select from list below to view details:

    • Personaleyes

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    OTHER: 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
    DEVICE: UV fs-Laser
    • Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
    OTHER: 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
    DEVICE: IR fs-Laser
    • Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 monthCorneal flap thickness will be measured using optical coherence tomography (OCT)Month 1

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation

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