Parkhurst NuVision is excited to offer a new IOL lens to San Antonio cataract patients. AcuFocus, Inc., a privately held ophthalmic medical device company, today announced U.S. Food and Drug Administration (FDA) approval for its breakthrough IC-8® Apthera™ intraocular lens (IOL) for the treatment of cataracts. The Apthera IOL is the first and only non-toric extended depth of focus IOL approved for the 82% of cataract patients who have as much as 1.5 diopters (D) of corneal astigmatism.
SAN ANTONIO, July 25, 2022 /PRNewswire-PRWeb/ -- The Apthera IOL is the first small aperture IOL to receive FDA approval, the first lens indicated for implantation with a monofocal or monofocal toric IOL in the fellow eye, the first extended depth of focus lens indicated for monovision, and the first non-toric IOL indicated for cataract patients with low amounts of corneal astigmatism.
Cataracts are a common condition affecting an estimated 24 million people in the United States. Cataracts can only be treated with surgery in which the cloudy natural lens is removed and an artificial lens, or IOL is implanted. The Apthera IOL, with its proprietary small aperture technology, seamlessly provides excellent distance vision and clear intermediate and near vision, effectively mitigating the effects of presbyopia.
Parkhurst NuVision was part of the clinical study that evaluated the safety and effectiveness of the Apthera IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye. A total of 453 subjects were enrolled and followed for 12 months. Outcomes for the Apthera IOL group (n=343) were compared to a control group (n=110) receiving a monofocal or monofocal toric IOL in both eyes. Apthera IOL treated eyes maintained 2 D of extended depth of focus and demonstrated 0.91 D of additional range of vision benefit over monofocal IOL eyes at 0.2 logMAR threshold, exceeding the 0.50 D ANSI criterion for extended depth of focus IOLs. Apthera IOL subjects achieved equivalent uncorrected distance vision and statistically superior intermediate and near vision compared to control subjects. Apthera IOL subjects also achieved comparable binocular contrast sensitivity to control subjects in both photopic and mesopic conditions, a first reported for an extended depth of focus lens.
"We are excited to be part of the clinical investigators for this new lens that will help cataract patients. Parkhurst NuVision is always looking for new innovations for laser eye surgery," said Gregory Parkhurst, MD of Parkhurst NuVision in San Antonio, TX.
Parkhurst NuVision plans to begin use of the Apthera IOL in the U.S. in the fall of 2022 when it becomes commercially available.
ABOUT THE IC-8® APTHERA™ IOL
The IC-8 Apthera IOL is a wavefront-filtering intraocular lens for unilateral implantation in patients who have as much as 1.5 D of corneal astigmatism in the implanted eye. This IOL, compared to a monofocal or monofocal toric IOL, provides an extended range of vision from distance through near. The Apthera IOL is the first extended depth of focus lens indicated for monovision.
As with any cataract surgery, risks of complications exist whether or not the IOL is implanted. The complications of IOL implantation surgery range from minor side effects (usually temporary) to serious complications. A full list of benefits and risks associated with the IC-8 Apthera IOL will be available online and the patient information brochure.
For more information about Apthera IOL or cataract procedures, please contact Parkhurst NuVision at [email protected]
Media Contact
Amanda Kincaid, Parkhurst NuVision, +1 2108184116, [email protected]
SOURCE Parkhurst NuVision
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