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So you’ve been considering LASIK and in the course of your research you keep coming across the results of clinical studies.
What are those? Do they matter? Should you pay attention to them?
In a word – yes!
Clinical studies, in a nutshell, are how we know what we know about LASIK and thousands of other medical treatments. They’re the way we’ve found out that LASIK is safe, effective, and a great vision correction option for thousands of people here in Charleston and beyond.
Over the course of centuries, scientists – including medical scientists – figured out a systematic way to test their ideas. Clinical research is what they do. Clinical studies are the way they do it.
Clinical research is a scientific medical exploration or investigation into the performance of a drug, medical device, or treatment regimen. Its purpose is to determine whether it is safe and effective for patients – under what circumstances, at what dose (if we’re investigating a drug), using what techniques (if we’re investigating a device or a procedure), and for which patients (what type or severity of a condition is being treated).
Clinical studies follow a strict series of steps. It begins with a hypothesis – that is, an educated guess about the treatment and its ability to provide a certain benefit. Then we conduct research to test whether the hypothesis is true or false.
The research itself can take many different forms. Sometimes a drug is tested against a placebo, or the drug is tested at several different dosages. A procedure or device is tested against an older version, a different therapeutic approach, or against a drug treatment. In every case, we collect data, analyze it in the context of the hypothesis, and then report the findings. The final report is reviewed by researchers who weren’t part of the study – their job is to make sure that the study is accurate and was conducted the right way. These researchers are our peers, and the work they do makes it a “peer-reviewed study.” That’s the gold standard for clinical research.
The findings of clinical research determine which drugs, devices, and treatments are approved by the U.S. Food and Drug Administration for use. Importantly, clinical research serves to build our knowledge about prevention, treatment, and diagnosis.
LASIK has been the subject of extensive clinical research – in fact, LASIK is one of the most studied elective procedures performed today. More than 9,000 patients participated in FDA clinical trials alone from 1993 through 2005. To date, more than 7,000 peer-reviewed LASIK studies have been published around the world. The studies confirm the procedure is both safe and effective and look into other important aspects of LASIK. The full body of LASIK research has helped us refine our understanding of what makes a patient a good or bad candidate for the procedure, as well as identifying techniques and technologies that can reduce the potential for side effects such as dry eye, glare, and halos.
Clinical studies have also tested the many improvements in LASIK since the procedure was first approved. In medicine, technologies, and techniques evolve and advance over time. LASIK is no different. Today’s excimer lasers – the lasers that reshape the cornea to improve vision – are more precise and easier to work with than earlier models. Newer lasers and technologies are able to customize the procedure to the specific shape and thickness of a patient’s cornea and treat a broader range of vision impairments. All of these advances lead to better visual outcomes and a safer procedure for more people.
What about those news stories about clinical studies? Chances are, the first time you came across a study, it was in a news report. And chances are, that story had big headlines and made sweeping statements about “breakthroughs.” But that’s how clinical research works and in fact, often does a disservice to the science involved. No one study delivers a final, definitive answer about any medical treatment, device, procedure, or drug. By definition, a study has a very specific scope of work – a specific question it is trying to answer. While the results of a single study can be compelling, interesting, and encouraging, each study is only a piece of a bigger and growing body of science. That’s why you have to be cautious about any reporting that describes dramatic conclusions from a single study.
If you want to use clinical studies to arrive at a better understanding of LASIK, you can read the studies themselves. Many are available online, or through local libraries. Some are highly readable, but others are quite technical. We often talk about LASIK studies on our blog in a way that makes the findings easy to grasp – here’s just one example. You can also visit the excellent American Refractive Surgery Council blog to find out more.
The best option, of course, is to schedule an appointment to come in and talk to us about your goals for LASIK, what it might mean for your life, and whether you’re a good candidate for the procedure. Whatever we conclude together, you can rest assured that our conclusions are the result of a deep understanding of the procedure. That’s the result of clinical research – science at its best!