Long-term Safety and Effectiveness of LASIK-Xtra Compared to Conventional LASIK (NCT06857032) | Clinical Trial Compass
By InvitationNot Applicable
Long-term Safety and Effectiveness of LASIK-Xtra Compared to Conventional LASIK
Germany12 participantsStarted 2024-08-01
Plain-language summary
Laser in situ keratomileusis (LASIK) is a widely used procedure for the correction of myopia and myopic astigmatism. Despite its high effectiveness and the general safety of the procedure, long-term safety and effectiveness remain a key concern in ophthalmology. A promising further development is the combination of LASIK with corneal UV-riboflavin crosslinking, which promises additional stability of the cornea.1 This study aims to evaluate the long-term safety and effectiveness of this combined method in comparison to classic LASIK. By analysing long-term results, the aim is to gain well-founded insights that will help to optimise the decision on the most suitable procedure for correcting myopia and myopic astigmatism and to ensure the best possible clinical results for patients.
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
. only patients who have successfully participated in the study with the clinicaltrials.gov registration number NCT 03913338 during the study period from 2014 to 2018 at the Department of Ophthalmology of the Goethe University Frankfurt will be included for the study to assess long-term outcomes and safety.
. adult men or women over the age of 18.
. subjects must be able to understand the requirements of the study and provide written informed consent.
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
Manifest refraction
Timeframe: single time point with one and only visit