How clinical research reveals the facts of LASIK

How clinical research reveals the facts of LASIK

September 29, 2016
by Parkhurst Nuvision

If you're thinking seriously about LASIK, you want to get the facts. There are many ways to do that. You can find answers to your questions through the American Refractive Surgery Council. You can explore LASIK in detail right here on our own website. Best of all, you can come in and have a discussion with us about the benefits, risks and lifestyle impact of LASIK, and talk about the most important question – whether LASIK is right for you.

But perhaps you might also want to ask another question – how do we know what we know about LASIK? Where do we get our answers?

To learn the facts about LASIK, we turn to a process called "clinical research."

Chances are, maybe on TV, in a newspaper or online, you've seen reports about a "clinical study." These stories often include compelling stats and comparisons and these findings often make good headlines.

But headlines – or news stories for that matter - can't cover the depth and breadth of the information presented in a clinical study.

Why? Because clinical research is conducted over months and years by scientists and the reports of those studies are incredibly detailed, running 20 to 100 pages or more.

So what exactly is clinical research?

Clinical research is a scientific medical exploration or investigation into the performance of a drug, medical device or treatment regimen with the primary goal of determining whether it is safe and effective for patients. It begins with a hypothesis – that is, an educated guess about the treatment and its ability to provide a certain benefit. Research is then conducted to test whether the hypothesis is true or false. Research can take many different forms, but essentially data is collected, analyzed in the context of the hypothesis and then the findings are reported. The findings of clinical research determine which drugs, devices and treatments are approved for use and often compares them to previously approved treatments. Importantly, clinical research serves to build our knowledge about prevention, treatment, and diagnosis.

Extensive clinical research has been conducted about LASIK. 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 1993-2005. LASIK has been the subject of more than 7,000 peer-reviewed published studies – designed to confirm the procedure is both safe and effective as well as look into other important aspects of LASIK. Among them are studies that help refine our understanding of what makes a patient a good or bad candidate for the procedure, and that shed light on 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.

The clinicians – the scientists – who work with LASIK are committed to an ongoing process of improvement in the procedure. These doctors continually ask questions as a means of finding potential in LASIK. There is a reason "quest" is the root of the word "question." This illustrates that scientific exploration is a process, a path – not necessarily a destination. The question is the beginning, not the end.

On this blog, we've reported on the results of many clinical studies about LASIK, including the FDA's PROWL study, which reports on patients' experiences after LASIK, and a review of a number of LASIK studies to see what they reveal about patient satisfaction. You can read about them here, if you'd like to know more about the kind of information that LASIK studies provide.

When you read about clinical studies, it's important to put them in context. News reports like to play up dramatic conclusions – in a news story, a study usually reveals a "breakthrough." Of course, that's because the media wants to grab your attention. In real life, it's more complicated. No one study provides a final, definitive answer about any medical treatment, device, procedure or drug. By definition, a study has a very specific scope – 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 body of science, one that's constantly growing. For that reason, you have to be cautious about any reporting that describes dramatic conclusions from a single study.

What the LASIK studies tell us, all taken together, is that there is tremendous confidence, based upon an extraordinarily large amount of clinically-based evidence, that the procedure is safe and effective. It isn't perfect, because nothing is. However, it ranks among the most thoroughly investigated, most effective and safest procedures performed today.



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