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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07036835
Registration number
NCT07036835
Ethics application status
Date submitted
17/06/2025
Date registered
25/06/2025
Date last updated
25/06/2025
Titles & IDs
Public title
Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation
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Scientific title
Clinical Investigation of the WaveLight® Ultraviolet Femtosecond Laser for Corneal Flap Creation
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Secondary ID [1]
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RFO268-C009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Refractive Errors
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - LASIK Surgery
Treatment: Devices - UV fs-Laser
Treatment: Devices - IR fs-Laser
Treatment: Devices - Anesthetic 1 eye drops
Treatment: Devices - Anesthetic 2 eye drops
Other: UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left - LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops
Other: UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right - LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops
Other: UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left - LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops
Other: UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right - LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops
Treatment: Surgery: LASIK Surgery
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
Treatment: Devices: UV fs-Laser
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
Treatment: Devices: IR fs-Laser
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
Treatment: Devices: Anesthetic 1 eye drops
Topical anesthetic used to numb the surface of the eye
Treatment: Devices: Anesthetic 2 eye drops
Topical anesthetic used to numb the surface of the eye
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Difference of intended and achieved flap thickness measured at center (i.e., corneal apex)
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Assessment method [1]
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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.
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Timepoint [1]
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Month 1
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Primary outcome [2]
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Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius)
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Assessment method [2]
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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.
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Timepoint [2]
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Month 1
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Primary outcome [3]
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Ability to lift flap at time of surgery
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Assessment method [3]
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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.
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Timepoint [3]
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Day 0 Surgery
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Primary outcome [4]
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Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser
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Assessment method [4]
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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.
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Timepoint [4]
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Day 0 Surgery up through Month 3
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Primary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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Month 1 up to Month 3
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Primary outcome [6]
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Number of device deficiencies
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Assessment method [6]
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A device deficiency is defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance.
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Timepoint [6]
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Day 0 Surgery through Month 3
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Eligibility
Key inclusion criteria
Key
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2026
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Actual
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Sample size
Target
174
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Personaleyes - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alcon Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07036835
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trial Lead, Surgical
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Address
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Alcon Research, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alcon Call Center
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Address
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Country
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Phone
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1-888-451-3937
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07036835
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