Santa Ana, CA. (June 18, 2018) – Johnson & Johnson Vision announced today the U.S. Food and Drug Administration (FDA) approval of the iDESIGN Refractive Studio, making it the only system to use topography-integrated, wavefront-guided technology.2 This allows doctors to take a precise measurement of the eye inside and out to deliver a LASIK procedure personalized to the individual patient. It is approved for myopia, hyperopia, and mixed astigmatism. Additionally, it is the only available LASIK platform indicated for monovision LASIK in presbyopic myopic patients. Monovision is a procedure designed for patients over 40 years old who are experiencing blurry near vision due to aging of their eyes. In the U.S., an estimated 130 million people3 could potentially benefit from a monovision procedure, which includes improved distance and near vision.
“As a practicing ophthalmologist for more than 25 years, I know firsthand the importance of taking precise measurements and tailoring LASIK procedures for each patient,” said Jonathan Talamo, MD, Chief Medical Officer and Worldwide Vice President of Medical and Clinical Affairs, Johnson & Johnson Vision. “The new iDESIGN Refractive Studio provides surgeons with the ability to deliver one-of-a-kind custom laser vision correction for each patient to have excellent visual outcomes following their LASIK procedure.”
In a single, three-second scan, the iDESIGN Refractive Studio offers a new level of customization for patients. Each treatment plan begins with a wavefront analysis to measure how light travels inside the eye, detailing the imperfections in a patient’s vision. The corneal topography scans the outside surface of the eye, measuring and analyzing tiny variations in curvature and elevation. The combination of the two measurements delivers a custom LASIK procedure tailored for each eye.
“The ability to perform monovision LASIK with iDESIGN Refractive Studio will benefit many patients and I’m proud to have been a part of that clinical investigation,” said Robert Maloney, MD, Maloney Vision Institute. “More patients are experiencing better quality outcomes with LASIK procedures and wavefront-guided treatments. This technology is truly revolutionizing how we measure and treat refractive errors.”
The majority of patients see 20/16 or better six months after laser vision correction based on clinical studies.4