Refractive ErrorsNCT07036835
Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation
A study testing LASIK Surgery, UV fs-Laser and IR fs-Laser in people with Refractive Errors, run by Alcon Research at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- LASIK Surgery, UV fs-Laser and IR fs-Laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Aug 2025to 21 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of the WaveLight® Ultraviolet 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.
Read the detailed 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.
- Conditions
- Refractive Errors
- Being tested
- LASIK Surgery, UV fs-Laser, IR fs-Laser, Anesthetic 1 eye drops, Anesthetic 2 eye drops
- Keywords
- LASIK
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIK SurgeryProcedure or surgery
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
UV fs-LaserDevice
Also called Model 1026
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
IR fs-LaserDevice
Also called Model 1025
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
Anesthetic 1 eye dropsDevice
Topical anesthetic used to numb the surface of the eye
Anesthetic 2 eye dropsDevice
Topical anesthetic used to numb the surface of the eye
| Study group | Role | What they receive |
|---|---|---|
| UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left | Other | LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops Receives: Procedure: LASIK Surgery; Device: UV fs-Laser; Device: IR fs-Laser; Device: Anesthetic 1 eye drops |
| UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right | Other | LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops Receives: Procedure: LASIK Surgery; Device: UV fs-Laser; Device: IR fs-Laser; Device: Anesthetic 1 eye drops |
| UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left | Other | LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops Receives: Procedure: LASIK Surgery; Device: UV fs-Laser; Device: IR fs-Laser; Device: Anesthetic 2 eye drops |
| UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right | Other | LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops Receives: Procedure: LASIK Surgery; Device: UV fs-Laser; Device: IR fs-Laser; Device: Anesthetic 2 eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 Surgery through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start27 Aug 2025
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036835
- Sponsor's protocol ID
- RFO268-C009
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No