Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation (NCT07036835) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation
Australia128 participantsStarted 2025-08-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference of intended and achieved flap thickness measured at center (i.e., corneal apex)
Timeframe: Month 1
2
Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius)
Timeframe: Month 1
3
Ability to lift flap at time of surgery
Timeframe: Day 0 Surgery
4
Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser
Timeframe: Day 0 Surgery up through Month 3
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