Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation
Clinical Investigation of the WaveLight® Ultraviolet Femtosecond Laser for Corneal Flap Creation
1 other identifier
interventional
128
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedStudy Start
First participant enrolled
August 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
April 13, 2026
April 1, 2026
10 months
June 17, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Difference of intended and achieved flap thickness measured at center (i.e., corneal apex)
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.
Month 1
Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius)
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.
Month 1
Ability to lift flap at time of 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.
Day 0 Surgery
Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser
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.
Day 0 Surgery up through Month 3
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
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.
Month 1 up to Month 3
Number of device deficiencies
A device deficiency is defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance.
Day 0 Surgery through Month 3
Study Arms (4)
UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left
OTHERLASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops
UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right
OTHERLASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops
UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left
OTHERLASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops
UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right
OTHERLASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops
Interventions
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
Topical anesthetic used to numb the surface of the eye
Topical anesthetic used to numb the surface of the eye
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Personaleyes
Sydney, New South Wales, 2000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Surgical
Alcon Research, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2025
First Posted
June 25, 2025
Study Start
August 27, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04