Long-term Safety and Effectiveness of LASIK-Xtra Compared to Conventional LASIK
This research looks at two types of laser eye surgery: standard LASIK and a slightly different procedure called LASIK-Xtra. Both aim to correct short-sightedness and blurry vision (astigmatism). While LASIK is very common, doctors are always looking at ways to make it even better and safer in the long term. LASIK-Xtra combines the standard LASIK procedure with an extra step using UV light and a special vitamin (riboflavin) to potentially make the eye's shape more stable. This study aims to find out if LASIK-Xtra offers the same safety and effectiveness as standard LASIK over many years. Researchers will check vision, how stable the eye's new shape is, and if there are any long-term problems or side effects.
At a glance
What is this study about?
This research study is all about laser eye surgery, a popular way to correct vision problems like short-sightedness (myopia) and blurry vision due to an uneven eye shape (astigmatism). The standard operation is called LASIK. While it's generally very safe and works well, doctors are always keen to understand how these treatments perform over many years.
This study is looking at a new version called LASIK-Xtra. This procedure is similar to standard LASIK but includes an extra step where doctors use UV light and a special vitamin called riboflavin on the eye. The idea behind this extra step is to make the cornea (the clear front part of your eye) even stronger and more stable after the surgery. The main goal of this study is to compare LASIK-Xtra with standard LASIK to see if both are equally safe and effective in the long run.
Researchers will be carefully checking several things, including how good people's vision is after many years, how stable their eyesight remains, and whether the shape and strength of their cornea stay the same. They will also be looking out for any potential long-term side effects. By understanding these long-term results, doctors can make the best choices when advising patients about which type of laser eye surgery might be most suitable for them.
Key takeaways
- Compares two laser eye surgeries: standard LASIK vs. LASIK-Xtra.
- Aims to check long-term safety and how well vision is corrected.
- Looks at patients who had surgery between 2014-2018 at Goethe University Frankfurt.
- Involves follow-up eye examinations, no new treatments.
- Goal is to help doctors advise patients on the best surgical option.
- Participants must be over 18 and have clear understanding of the study.
Who may be eligible?
To be part of this study, you must have previously taken part in an earlier laser eye surgery study (registered as NCT 03913338) that happened between 2014 and 2018 at the Eye Department of Goethe University Frankfurt.
You must be 18 years old or older. You also need to be able to understand what the study involves and be willing to give your written permission to take part. Researchers are specifically looking at patients who had LASIK-Xtra in one eye and standard LASIK in the other eye during that previous study timeframe.
You cannot take part if you are an employee, a relative, or a close friend of someone who works at an eye clinic or for a company involved in eye health research (like the researchers or their staff).
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Did you have laser eye surgery at Goethe University Frankfurt between 2014 and 2018?
- Did you take part in the previous study with registration number NCT 03913338?
- Are you 18 years old or older?
- Are you able to understand the study information and give written permission to take part?
- Are you not closely related to or an employee of any eye clinic or research company involved?
What does participation involve?
If you are eligible, taking part in this study would involve a follow-up eye examination. This examination would be similar to your usual eye check-ups. The researchers will be looking at things like your vision, the shape of your eye, and its internal pressure. They will also check for any changes in your cells at the back of your eye. These tests are not invasive, meaning they don't involve cuts or needles. The study involves looking back at your medical records from the original surgery and then having a new, up-to-date eye check-up. The exact number of visits isn't specified, but it suggests one follow-up examination to gather your current eye health data.
Potential risks and benefits
Locations (1)
- University Clinic Frankfurt, Goethe UniversityVerified postcodeFrankfurt am Main, Germany
Common questions
What is LASIK-Xtra?
LASIK-Xtra is a type of laser eye surgery similar to standard LASIK, but it includes an extra step using UV light and a special vitamin to potentially make the eye's shape more stable.
What vision problems does this study look at?
This study focuses on correcting short-sightedness (myopia) and blurry vision caused by an uneven eye shape (astigmatism).
Will I get new treatment in this study?
No, this study is about checking the long-term results of surgery you had between 2014 and 2018. It involves follow-up examinations, not new treatments.
What does 'non-invasive examinations' mean?
It means the tests don't involve anything entering your body, like needles or surgery. They are usually visual checks or using machines to scan your eye without touching it directly.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time without having to give a reason, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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