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Achroma intraocular lens9/3/2023 ![]() The control group received monofocal intraocular lenses in both eyes.Īt 6 months after surgery, people who received IC-8 Apthera reported better near and intermediate visual acuity and comparable distance vision to the control group. One group, the treatment group, received the IC-8 Apthera in one eye and a monofocal control intraocular lens in the other. In that study, 453 people had intraocular lenses implanted in both eyes. The safety and effectiveness of the IC-8 Apthera IOL was studied in a non-randomized, controlled, clinical trial. The IC-8 Apthera IOL improves near and intermediate vision compared to conventional monofocal lenses that provide improved vision at far distances only. It is implanted in the non-dominant eye only after the dominant eye has undergone successful implantation of a monofocal or monofocal toric intraocular lens targeted for distance vision (emmetropia). The IC-8 Apthera IOL is used in adults who have cataracts, need eye surgery, and have only a small amount (1.5 diopters or less) of abnormal curve to the cornea (astigmatism). It focuses light through a small hole (pinhole optics) in the lens which allows the user to focus on objects close up (intermediate and near vision) while maintaining the ability to focus on objects far away (distance vision), which is the intended purpose of standard (monofocal) IOLs. The IC-8 Apthera lens is an extended depth of focus intraocular lens. The IC-8 Apthera IOL works by bending light rays to allow them to focus on the back surface of the eye (retina). The lens is intended to provide vision correction after the eye’s natural lens is removed because it has become cloudy ( cataract). The IC-8 Apthera Intraocular Lens (IOL) is an artificial lens implanted in the eye of adult patients. Product Name: IC-8 Apthera Intraocular Lens (IOL)Īddress: 32 Discovery, Suite 200, Irvine, CA 92618 USAĪpproval Letter: Approval order What is it? See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Any upgrade is an out-of-pocket expense, which varies depending on the lens selected.This is a brief overview of information related to FDA’s approval to market this product. Only monofocal lenses are fully covered by insurance. We also implant Johnson & Johnson TECHNIS® multifocal lenses, including the Symfony® lens, which offers both multifocality and enhanced depth of focus.īecause we offer the full line of premium lenses, we’re able to select the type of lens that is best suited to each patient’s eye and visual needs. Results for the newer Vivity® lens show a similar degree of patient satisfaction.The FDA trial for the PanOptix® lens resulted in more than 99% of the patients studied saying they would have the lens implanted again.They can provide good near, medium, and distance vision without the need for eyeglasses or contact lenses.Clinical studies of these lenses have shown that: Most monofocal, multifocal, trifocal, and EDOF lenses come in toric versions.Īt UT Southwestern, we offer various types of IOLs, such as the AcrySof PanOptix® and Vivity® family of trifocal and EDOF IOLs. Toric: This lens has different focusing powers in different areas of the lens to correct astigmatism (irregularly shaped cornea).They may have specific advantages over trifocal lenses in certain patients, such as people who have had LASIK. Extended depth of focus (EDOF) or extended range of vision: These lenses have the potential to give patients distance, medium, and even some near vision. ![]() Trifocal lenses, which can focus at all distances, are the most advanced version of these lenses. Trifocal or multifocal: These lenses have multiple focusing distances in different areas of the lens, capable of bringing into focus objects that are at a far, medium, or close distance from the patient’s eye.Monofocal: This lens has one focusing distance, providing either near, medium, or distance vision.We work closely with patients who have cataracts or presbyopia to determine the best type of IOL for their specific needs. Our eye surgeons offer expert diagnosis and treatment in all areas of eye care.
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