FDA Study Of Next Generation Customized Wavefront PRK Show Stunning Results
Customized Wavefront PRK (or “flapless LASIK”) has already established itself as a superb techology and has been used by both the US Air Force and the US Navy for their most elite fighter pilots. A next generation wavefront technology was recently introduced and the FDA data show amazing results. This new, groundbreaking technology is the technology we now use at the Shapiro Laser Eye Center for customized wavefront PRK and customized wavefront LASIK.
What is PRK?
PRK, or photorefractive keratecomy, is LASIK without a flap. Instead of creating a flap and applying the laser beam to the interior of the cornea and replacing the flap, the same laser is simply applied to the surface of the cornea without a flap. Recovery times are longer for PRK than for LASIK but PRK has advantages over LASIK in other ways.
What is Customized Wavefront Technology?
Customized wavefront laser technology is different from convenetional laser technology in that the optics of the eye are measured differently so there is different information used to program the laser treating the eye for PRK or LASIK. With conventional laser technology, the surgery is simply based on the “which is better, one or two” test that is used to make glasses or contact lenses. Whatever answer the patient gives to the doctor goes into the laser and then onto the eye. With customized wavefront technology, instead of using the “which is better, one or two” test to measure the eye, an invisible infra-red laser beam is shined into the eye to measure the optics of the eye by seeing how the eye affects the optical pathway of the laser as it bounces off the back of the eye and returns to exit the eye. A map is made of how the wavefront of returning light has been distorted by the eye. This map is unique to each eye and is called the “optical fingerprint” of the eye. This is far more accurate than using conventional measurements and also is not based on the patient’s opinion — it is an objective measurement taken with lasers. In this way, each treatment is customized to the unique optical properties, or optical fingerprint, of each patient’s eye.
How is the Next Generation Customized Wavefront Technology Different?
Customized wavefront technology was invented by NASA for use in astrophysics. The original customized wavefront measurement devices used for LASIK incorporated NASA’s methods of analyzing the optical measurements. This original wavefront technology is still in use in many places in the United States today and produces excellent results. The next generation customized wavefront technology that we are now using at the Shapiro Laser Eye Center has 50 times the resolution of these systems originally introduced by NASA. This introduces a new era of “ultra high resolultion” customized wavefront technology. In addition to the extremely high resolution meaurements, the next generation wavefront measurements also incorporate a topographical map of the surface of the cornea and integrates that data into the customized wavefront data, something no previous customized wavefront treatments did.
What Does the FDA Data Show?
The FDA data for using this next generation wavefront technology in the format of PRK is the best data I have seen for any laser platform and technique. In the FDA clinical trials (PMA data) for nearsighhtedness with or without astigmatism for adults 18 years or older, 322 cases were studied. 100% of cases could pass a driver’s test (20/40 or better vision), 99% of cases achieved 20/20 vision, and 92% of cases had better than 20/20 vision (20/16 or better vision). In terms of night vision, there was a 64% increase in patients who said they could drive at night with no difficulty when compared to using their glasses or contacts for driving at night before surgery. This data is consistent with the results we are seeing at the Shapiro Laser Eye Center with this technology and similar to the results of a groundbreaking joing US Air Force, US Navy, US Army study of this advanced technology. (PMA P930016/S057 Summary of Safety and Effectiveness Data)
How Does this FDA Data Compare to Other Modern Laser Platforms?
This FDA data for next generation ultra-high resolution customized wavefront PRK is the best FDA data I have seen to date for laser vision correction and this is the technolgoy I prefer. For comparison, the FDA data for the Alcon Allegretto (lower resolution) Wavefront Guided LASIK showed 93% of patients achieving 20/20 vision, while Alcon Allegretto Contura (topographically guided) and Alcon Allegretto Wavefront Optimized (a version of conventional surgery) also each showed 93% of patients achieving 20/20 vision. SMILE (small incision lenticular extraction — a different laser techniqe than either LASIK or PRK) showed 84% of patients achieving 20/20 vision. Alcon Allegretto Contura topographically guided LASIK shows improved results if an additional software called Phorcides is incorporated. (Lobanoff M, Understanding the Eye’s “Fingerprint”, Ophthalmology Management, June 2021, p. 22).