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

Sponsor
Alcon Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06021353
Collaborator
(none)
66
Enrollment
2
Locations
2
Arms
6
Anticipated Duration (Months)
33
Patients Per Site
5.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: UV fs-Laser
  • Device: IR fs-Laser
  • Procedure: LASIK
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 Names:
  • WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507

    • Procedure: LASIK
    Laser-assisted in situ keratomileusis (LASIK) surgery
    Active Comparator: 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
    Other Names:
  • WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515

    • Procedure: LASIK
    Laser-assisted in situ keratomileusis (LASIK) surgery

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Personaleyes Sydney New South Wales Australia 2000
    2 Laservision.gr Institute Athens Greece 11521

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Principal Clinical Trial Lead, CRD Surgical, Alcon Research, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT06021353
    Other Study ID Numbers:
    • RFO268-E005
    First Posted:
    Sep 1, 2023
    Last Update Posted:
    Sep 1, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Sep 1, 2023