Lenstec, Inc. — a manufacturer of technologically-advanced implantable lenses — today announced that the U.S. Food and Drug Administration has approved the company’s Softec HD™ Intraocular Lens Implant (IOL) for treating patients with cataracts. The newly approved Softec HD is part of Lenstec’s “Precision Series” of implantable IOLs that enable ophthalmologists to achieve previously unattainable predictability and precision in vision surgery.
Targeting a Growing Problem Worldwide
Cataract formation is among the leading causes of blindness. While not generally amenable to prevention, cataracts can usually be treated with surgery in which an IOL is used to replace the damaged natural crystalline lens. According to the World Health Organization, the number of cataract operations internationally will grow to 20 million this year, up from seven million in 2000. The Softec HD is already in widespread use throughout the European Union, Australia, Canada, China and other international markets. More than one million Softec IOLs have been implanted worldwide since 2005.
With today’s approval announcement, cataract patients in the U.S. can now benefit from Softec HD’s advanced technology, which will be on display April 9-14 at the ASCRS (American Society of Cataract and Refractive Surgeons) Symposium & Congress in Boston (Booth # 2272).
Based on Lenstec’s proprietary lens manufacturing technology, the Softec HD is designed to make cataract surgery more predictable by reducing the variability inherent in any manufactured lens. When it comes to lenses used for vision correction, variability is defined as the tolerance or margin of error measured by the difference between a lens’ labeled prescription and its actual power. The Softec HD is manufactured with a tolerance of just 0.125D (diopters), which is up to three times more precise than cataract replacement lenses manufactured under less stringent ISO standards.
“Lens variability is one of the leading causes of refractive error for patients who undergo cataract surgery,” said Lenstec Vice President Jim Simms. “Our ‘Precision Series’ technology reduces such variability and enables surgeons to better target each patient’s prescription.”
William F. Maloney, M.D., associate clinical professor of ophthalmology at the University of California, Irvine, has cautioned surgeons for years about the problems associated with lens variability.
“The accuracy of the IOL prescription label is now likely to be the greatest source of refractive error in your surgery,” Dr. Maloney warned in the September 2005 issue of Ocular Surgery News. “When it comes to power, what you see is definitely not what you get. The tolerance for error in most IOL labeling is now obsolete, and it too fails today’s refractive accuracy test. Until that changes, your efforts at refractive recalibration will be hostage to this outdated industry standard.”
Simms added, “The only way to reduce such variability is to manufacture a more precise lens. While this requires more effort, we have been able to make the process scalable in a way that larger implantable lens manufacturers with legacy systems simply can’t match.”
In addition to reducing variability, Lenstec’s high-precision manufacturing process makes it possible to produce Softec HD lenses in 0.25D increments for prescriptions from +18D to +25D. In contrast, standard IOLs from other manufacturers are available only in 0.5D increments, which means they can be up to 0.25D out of step with a patient’s lens prescription.
“Today’s announced approval of the Softec HD means that U.S. surgeons now have the technology to address concerns about lens variability head-on and provide cataract patients with a new, vastly superior level of predictability and precision,” Simms concluded.
Cataract formation is a vision disorder characterized by cloudy or opaque areas in the eye’s natural lens that usually develop gradually with advancing age (environmental factors, metabolic diseases and certain medications can also accelerate cataract formation).