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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06021353
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : March 25, 2024
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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
Refractive Errors Device: UV fs-Laser Device: IR fs-Laser Procedure: LASIK Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel 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
Actual Study Start Date : October 20, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515

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


Outcome Measures
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Primary Outcome Measures :
  1. Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month [ Time Frame: Month 1 ]
    Corneal flap thickness will be measured using optical coherence tomography (OCT)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021353


Contacts
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Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

Locations
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Australia, New South Wales
Personaleyes Recruiting
Sydney, New South Wales, Australia, 2000
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Principal Clinical Trial Lead, CRD Surgical Alcon Research, LLC
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT06021353    
Other Study ID Numbers: RFO268-E005
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: March 25, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Refractive Errors
Eye Diseases