The first patients were commercially implanted with a small aperture, non-toric extended depth of focus intraocular lens (IC-8 Apthera IOL) for the treatment of cataracts, according to a press release from AcuFocus, Inc. The IOL is FDA-approved for cataract patients who have as much as 1.5 diopters (D) of corneal astigmatism.
“These initial surgeries mark the start of our controlled limited commercial release of the Apthera IOL,” said Al Waterhouse, president and chief executive officer for AcuFocus in the press release. “This is an exciting milestone in our series of firsts: 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.”
FDA approval was based on data from the U.S. Investigational Device Exemption study in which patients (n = 343) had Apthera IOL implants in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye. Patients in the control group (n = 110) received a monofocal or monofocal toric IOL in both eyes. Patients were followed for 1 year.
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 patients achieved equivalent uncorrected distance vision and statistically superior intermediate and near vision compared to control subjects. Apthera IOL patients 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.
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