Creating LASIK Flaps With the LenSx Femtosecond Laser (NCT01556893) | Clinical Trial Compass
CompletedPhase 1
Creating LASIK Flaps With the LenSx Femtosecond Laser
Hungary20 participantsStarted 2012-04
Plain-language summary
This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.
Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.
Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.
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.
Inclusion criteria
. Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
. Must be over 18 years of age
. Must have visual acuity correctable to at least 20/25 in both eyes
. If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
. Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
. Must sign and be given a copy of the written Informed Consent form
. Postoperative refractive target is emmetropia
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.
. Known sensitivity to planned study concomitant medications
. Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
. Presenting any contraindications to femtosecond initiated LASIK
. Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
. Irregular astigmatism, based on Investigator's judgment
. Undergoing monovision LASIK
. Pregnant, lactating or plan to become pregnant during the course of this study
. For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.