Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07036835

Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

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. 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.

Who can participate

Healthy volunteers accepted: No

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

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.

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 or confound the outcomes of the study;
  • Current use of medications with known ocular side effects and photosensitivity;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

LASIK surgery

Procedure

Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error

UV fs-Laser

Device

WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery

Other names: Model 1026

IR fs-Laser

Device

WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery

Other names: Model 1025

Anesthetic 1 eye drops

Device

Topical anesthetic used to numb the surface of the eye

Anesthetic 2 eye drops

Device

Topical anesthetic used to numb the surface of the eye

Primary outcomes

  1. Difference of intended and achieved flap thickness measured at center (i.e., corneal apex)

    Time frame: Month 1

    Optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures, will be used to measure the thickness of the cornea. This endpoint is pre-specified for the UV fs-Laser only.

  2. Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius)

    Time frame: Month 1

    Optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures, will be used to measure the thickness of the cornea. This endpoint is pre-specified for the UV fs-Laser only.

  3. Ability to lift flap at time of surgery

    Time frame: Day 0 Surgery

    The surgeon will record a response on a questionnaire indicating ability to lift the corneal flap at time of surgery (unable to lift flap / able to lift flap). This endpoint is pre-specified for the UV fs-Laser only.

  4. Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser

    Time frame: Day 0 Surgery up through Month 3

    An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons. AEs pertaining to corneal flap creation that are attributable to the laser will be recorded.

  5. Flap-related loss of best-corrected distance visual acuity (BCDVA) greater than or equal to 2 lines (greater than or equal to 10 letters logMAR) at 1 month postoperative or later

    Time frame: Month 1 up to Month 3

    Visual acuity will be assessed with correction in place (phoropter or trial frame) at a distance of 4 meters under well-lit conditions using letter charts.

  6. Number of device deficiencies

    Time frame: Day 0 Surgery through Month 3

    A device deficiency is defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Investigation of the WaveLight® Ultraviolet Femtosecond Laser for Corneal Flap Creation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Apr 13, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.