Boca Raton, Fla. — The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC, announced the publication of peer-reviewed clinical data supporting the performance of the Deseyne daily disposable contact lens for presbyopia.
The study, published in Optometry and Vision Science, found that the lens significantly increased depth of focus and improved near and intermediate vision compared with a monofocal control lens while maintaining distance vision.
Deseyne is an FDA-cleared daily disposable soft contact lens that uses Extended Depth of Focus technology. The companies said the publication marks the first peer-reviewed clinical validation of the lens.
“Bringing the first FDA-cleared daily disposable EDOF lens for presbyopia from concept to peer-reviewed publication is a milestone for our team and for the category,” said Eddie Catalfamo, Co-founder and Chief Executive Officer of The Cataltheia Group and co-author on the study. “Presbyopia is one of the largest unmet needs in vision care, and our goal with Deseyne® is to give eye care professionals a meaningful new option for their patients.”
The randomized, crossover clinical trial enrolled 78 habitual soft contact lens wearers with presbyopia between the ages of 45 and 70 at three U.S. sites. The study was led by Mark A. Bullimore, MCOptom, PhD, FAAO, and other researchers.
Deseyne increased depth of focus by 0.78 diopters compared with the monofocal lens. Participants experienced approximately 1.6 lines of improvement in near visual acuity and 1.4 lines of improvement in intermediate visual acuity.
Distance visual acuity remained statistically noninferior to the control lens, and no adverse events were reported during the study.
Participants ages 60 and older experienced a 0.88-diopter increase in depth of focus, along with approximately two lines of improvement in near vision and 2.2 lines of improvement in intermediate vision.
Unlike conventional multifocal contact lenses, which typically use multiple optical powers, concentric zones or simultaneous-image designs, Deseyne uses an optical architecture intended to expand the range over which objects remain in acceptable focus.
Because established performance criteria for EDOF contact lenses were not available, researchers evaluated the lens using the FDA-recognized ANSI Z80.35-2018 framework for extended-depth-of-focus intraocular lenses.
The study found that Deseyne met the framework’s criteria for increased depth of focus, intermediate visual acuity and noninferior distance vision compared with a monofocal control.
Presbyopia is an age-related condition in which the eye’s natural lens loses flexibility, reducing the ability to focus on nearby objects. The condition generally affects people beginning in their 40s and is estimated to affect about 139 million Americans.
“Many patients drop out of soft contact lens wear in their 40s and 50s because of presbyopia leading to poorer near vision. The availability of the first FDA approved extended depth of focus soft contact lens provides an exciting new option for practitioners,” said Mark Bullimore, MCOptom, PhD, FAAO. “This published paper provides the evidence base to help doctors make informed decisions when considering this lens for their patients, for example, what intermediate and near visual acuity can be expected?”
