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OpenTrials
Completed

NCT Number: NCT06021353

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

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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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Personaleyes

Sydney, New South Wales, 2000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UV fs-Laser

Device

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

IR fs-Laser

Device

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

LASIK

Procedure

Laser-assisted in situ keratomileusis (LASIK) surgery

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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