Ophthalmology equipment company Keranova has announced positive clinical study reports for its robotic laser technology, which it says will open the door to a “new technique in cataract surgery for the first time in decades”.
Keranova said its FemtoMatrix technology uses a world-first procedure called PhotoEmulsification.
The company now aims to secure CE marking in coming months to bring the technology to market in Europe this year.
“This is the first time that a new surgical technique, PhotoEmulsification, has been performed, the latest landmark in cataract surgery since phacoemulsification in the late 1980s,” Keranova said in a news release announcing the trial results.
“The results are extremely positive and should benefit both surgeons and patients.”
A randomised comparative multicentre pivotal study was carried out last year in the Czech Republic, with 54 patients enrolled.
The contralateral eye of each patient was treated using the traditional method by phacoemulsification to serve as control. The study demonstrated FemtoMatrix’s ability to eliminate the use of ultrasound in the vast majority of cases on a standard population, or to reduce it drastically.
“Surgeons will be able to perform perfectly calibrated cataract surgery and reduce the risks associated with handling the ultrasound device used in a classic phacoemulsification.
“They can now perform cataract surgery without ultrasound as efficiently as current techniques, but with greater precision and reduced risks of corneal/iris damage, capsular ruptures or adverse consequences on the retina, all within the same operating time,” the company said.
Founder and CEO of Keranova, Fabrice Romano, described PhotoEmulsification technology as the third generation of cataract surgery technology, after manual extracapsular and phacoemulsification.
The full results of Keranova’s clinical regulatory studies will be published in several peer-reviewed journals this year.