FDA Approves Customized LASIK Treatment iDESIGN Refractive Studio

The US Food and Drug Administration (FDA) announced the approval of iDESIGN Refractive Studio for myopia, hyperopia and mixed astigmatism, making it the only system to utilize topography-integrated, wavefront-guided technology, announced Johnson & Johnson Vision.

The technology allows physicians to take a precise measurement of the eye inside and out, delivering a laser assisted in situ keratomileuses (LASIK) procedure personalized to each patient. This is the only available LASIK platform indicated for monovision LASIK in presbyopic myopic patients.

“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,” Jonathan Talamo, MD, chief medical officer, worldwide vice president of medical and clinical affairs, Johnson & Johnson Vision, said in a statement. “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.”

The iDESIGN Refractive Studio offers a new level of customization for patients in a single, 3-second scan, and is 25 times more precise than the traditional way of measuring refractive errors.

Treatment plans begin with a wavefront analysis in order 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 to measure and analyze tiny variations in curvature and elevations. The combination of the 2 measurements delivers a custom procedure tailored for each eye.

Based on clinical studies, a majority of the patients utilizing this technology see 20/16 or better 6 months after laser vision correction.

The safety and effectiveness is not established in patients with a known opacity of the lens or cornea, including those with cataracts, corneal scars or dry eye syndrome.

iDESIGN Refractive Studio will be commercially available in Q3 2018.