Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

Last updated: January 12, 2026
Sponsor: Alcon Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Treatment

IR fs-Laser

UV fs-Laser

Anesthetic 1 eye drops

Clinical Study ID

NCT07036835
RFO268-C009
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to see how safe the WaveLight Ultraviolet Femtosecond Laser, Model 1026 (UV fs-Laser), is for creating corneal flaps during laser-assisted in situ keratomileusis (LASIK) surgery. This study will be conducted in Australia.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Eligible for LASIK treatment;

  • Myopia as specified in the protocol;

  • Uncorrected distance visual acuity of greater than or equal to 0.30 logMAR;

  • Best corrected distance visual acuity of less than or equal to 0.10 logMAR;

  • Presence of clear natural lens (non-cataractous eye);

  • Other protocol-defined inclusion criteria may apply.

Exclusion

Key Exclusion Criteria:

  • An active implanted device for which laser use may be a contraindication;

  • Previous ocular surgery;

  • Ocular conditions that may affect subject safety or impact study outcomes;

  • Acute or chronic disease or illness that would increase the operative risk orconfound the outcomes of the study;

  • Current use of medications with known ocular side effects and photosensitivity;

  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 174
Treatment Group(s): 5
Primary Treatment: IR fs-Laser
Phase:
Study Start date:
August 27, 2025
Estimated Completion Date:
November 30, 2026

Study Description

Subjects who qualify to participate will have both eyes treated. Each subject will be randomly assigned to 1 of 2 topical anesthetics (numbing eye drops) and each eye will be randomly assigned to either the UV fs-Laser or the WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).

Subjects will attend a total of 6 scheduled study visits, including a preoperative Screening Visit (Day -45 to -1), a Surgery Visit (Day 0), and 4 postoperative visits at Day 1, Week 1, Month 1, and Month 3/exit, for a total individual duration of participation of approximately 4 months.

Connect with a study center

  • Personaleyes

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Personaleyes

    Sydney 2147714, New South Wales 2155400 2000
    Australia

    Active - Recruiting

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