What’s a “Clinical Study” – and What Does It Mean to You?Wednesday, January 16th, 2013, 5:58 pm
If you’re thinking about LASIK – or if you’ve taken the next step and started researching the procedure in earnest – you’ve probably come across “clinical studies” reporting that LASIK is safe and effective. But what are those studies? How are they conducted? What do they really mean for you?
If you watch the news or read the paper, you’ve likely heard reports about clinical studies or clinical research. Sometimes the reports are easy to understand. Sometimes they aren’t. Sometimes the reports make them seem dramatic (“Breakthrough!”) or frightening (“Danger!”). The truth is usually more complicated than that, because the studies are science, and science is about facts, not drama.
Clinical research is a kind of scientific study. It explores whether a medicine, medical device or treatment regimen is safe and effective. Clinical research starts with a hypothesis – an informed assumption that a treatment will provide a certain benefit – then tests it to find out if it’s true.
The findings of clinical research build our knowledge about which treatments work and which ones don’t. They’re used by regulators like the U.S. Food and Drug Administration (FDA) to determine which drugs, devices and treatments are approved for use. The process is careful and methodical. Clinical research is evaluated prior to performing the study by a review board and then prior to publication experts in the field look over the study carefully to make certain it is worthy of publication.
Let’s look at LASIK, for example. LASIK is one of the most studied elective procedures performed today. From 1993 until 2005, more than 9,000 patients participated in FDA clinical trials alone. The role of the first studies was to determine if LASIK was safe, and if it corrected vision effectively. Over time, once those questions were answered (the answers were “yes!” and “yes!”), researchers moved on to follow-up studies that looked into ways to better screen out people who aren’t good candidates for LASIK and to reduce the potential for side effects including dry eye, glare and halos.
In addition, clinical trials have 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 are more precise and even safer (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 for more people.
Research into LASIK will continue – because doctors and scientists will always have questions about how to make it better. Questions are the spark for science – without questioning and curiosity, science simply wouldn’t exist. There is a reason “quest” is the root of the word “question.” Scientific exploration is a process, a path – not necessarily a destination. The question is the beginning, not the end. As the quest for ways to improve LASIK continues, we can look forward to taking an already excellent procedure and finding out more – while creating even better LASIK techniques – in the future.