One of the exciting aspects of life in the 21st century is living with the anticipation of ever-advancing technology. Whether it’s a new computer, a new phone, or a new watch, new technology continually promises to improve our lives in tangible ways. In the United States, the regulatory oversight by the FDA makes this a prolonged and punctuated process for medical devices. Although it does take longer for medical devices to become available in the United States, when they do, they come with some of the best data in the world regarding their claimed and actual performance.
With the excitement of new technology comes the responsibility of each surgeon to determine if, when, and how we are going to adopt it into our practice. We must perform some sort of mental assessment of the risks, benefits, and potential impact of each device—both to the patient and to our practice. Fortunately, with FDA approval comes easy and open access to data from the PMA clinical trials. Although the data from these multimillion-dollar studies—as well as the experience of the clinical investigator who performed the trials—can be truly helpful in evaluating new medical devices, nothing can replace the knowledge and understanding gained from our own firsthand experience.
ADVANCES IN PRESBYOPIA CORRECTION
For the surgical correction of presbyopia, we have recently received several exciting FDA approvals, including two new low-add versions of the Tecnis Multifocal IOL (Abbott Medical Optics) and the Kamra corneal inlay (AcuFocus)—the first in an entire new category of surgical solutions for presbyopia.
Broadly speaking, innovation can be grouped into two categories: (1) iterative improvement of existing technology and (2) paradigm-shifting introduction of new technology. The former represents a refinement or modification of a product that we already have (like the low-add Tecnis Multifocal IOLs), and the latter represents an entirely new approach to treating presbyopia (like the Kamra inlay).
For devices that are iterative improvements over current technology, such as the low-add Tecnis Multifocal IOLs, the clinical effects are relatively simple to extrapolate. In this case, we gain a longer near focal point and reduced halo size. Although the subjective clinical impact of these changes may be more difficult to quantify, the FDA data show that compared with the monofocal control, patients with the low-add Tecnis Multifocal IOLs (+2.75) reported fewer problems with night vision than the monofocal control. In my personal experience, the FDA data on night vision symptoms correlate with my greater confidence in providing these Tecnis Multifocal IOLs to younger, more active patients.
For devices representing paradigm-shifting technologies, such as the Kamra inlay, more careful consideration should be taken by surgeons; more uncertainty exists when making the transition from an investigational device in a highly controlled clinical trial to a viable clinical option with possible off-label uses. In these cases, package inserts capture only part of the picture. When a device is new, it may be challenging to find surgeons with clinical experience; however, FDA clinical investigators and surgeons from regions with earlier regulatory approval, including Europe, Canada, Latin America, and Asia, can share their valuable experience. Although it is unfortunate that the United States is no longer known as the introducer of new technology (credit the FDA for recent efforts to accelerate the approval process), US surgeons can learn from the experience of their international colleagues.
With the continued advancement of technology, we must be mindful—combining our desire for innovation with a healthy dose of skepticism—as we evaluate new options. We want to give our patients not just the latest but the greatest options available for their individual needs, and only we, their personal surgeons, can determine which technology is best to conquer their presbyopia.