FDA approves IC-8 Apthera IOL
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AcuFocus received FDA approval for its IC-8 Apthera small-aperture IOL for cataract surgery, according to a press release.
The extended depth of focus lens will be launched with a limited commercial release in the fall.
The IOL has small-aperture technology that filters out peripheral defocused light, which allows only focused light to reach the retina, the release said. In the U.S. investigational device exemption study, which included 453 participants and evaluated the effectiveness and safety of the lens, the Apthera IOL implanted in one eye and a monofocal or monofocal toric IOL in the fellow eye achieved statistically superior uncorrected intermediate and near vision compared with a control group with monofocal or monofocal toric IOLs in both eyes. Participants with the Apthera IOL also had equivalent distance vision and contrast sensitivity as the control group.
“The Apthera IOL represents several firsts for surgeons and patients: 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,” Al Waterhouse, president and CEO of AcuFocus, said in the release.
Perspective
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This new lens represents a major addition to the market, particularly for patients with irregular corneas who may not be candidates for presbyopia or astigmatism-correcting IOLs. The small aperture of the IC-8 has already been shown outside the U.S. to work extremely well for patients with previous radial keratotomy, scars or other abnormalities. And when targeted for about –1.0 sphere, it is likely to provide some depth of focus from distance to intermediate and near that is very pleasing for these challenging patients.
Perspective
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It is so exciting that we now have the pinhole optic IOL available to use for our patients. This will give patients an option for a true enhanced depth of focus IOL and additionally may give patients with irregular corneas a chance at improved optics.
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