FDA Approves iDESIGN Refractive Studio Allowing for Customized LASIK Treatment

Source: Johnson & Johnson Vision

Johnson & Johnson Vision announced the FDA approval of the iDESIGN Refractive Studio, making it the only system to use topography-integrated, wavefront-guided technology. The device allows doctors to take a precise measurement of the eye to deliver a LASIK procedure personalized to the individual patient, according to Johnson & Johnson Vision.

The iDESIGN is approved for myopia, hyperopia, and mixed astigmatism, and is the only available LASIK platform indicated for monovision LASIK in presbyopic myopic patients.

“It’s the first and only system that uses topography-integrated, waveFront-guided technology for laser vision correction in the U.S. It’s also the only available LASIK platform indicated for monovision LASIK in presbyopic myopic patients,” Jonathan Talamo, MD, Chief Medical Officer and Worldwide Vice President of Medical and Clinical Affairs, Johnson & Johnson Vision, said in an interview with Eyewire News. “Other treatments are driven by a phoropter, but the iDESIGN Refractive Studio’s measurements are objective, so it removes guesswork because it doesn’t require feedback from the patient.”

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,” Robert Maloney, MD, Maloney Vision Institute, said in a company news release. “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 6 months after laser vision correction based on clinical studies. The iDESIGN Refractive Studio will be marketed by Johnson & Johnson Surgical Vision and be commercially available in Q3 2018.


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