Eyeworld

by Title Heading Name title Contact Name: email ATARACT C EVOLVING 32 | EYEWORLD | WINTER 2024 How to talk to patients about IOL options © 2024 Alcon Inc. 05/24 US-CLI-2400063 IMPORTANT PRODUCT INFORMATION: CLAREON ® FAMILY OF IOLS CAUTION: Federal law restricts these devices to sale by or on the order of a physician. INDICATION: The family of Clareon ® intraocular lenses (IOLs) includes the Clareon ® Aspheric Hydrophobic Acrylic and Clareon ® Aspheric Toric IOLs, the Clareon ® PanOptix ® Trifocal Hydrophobic IOL, Clareon ® PanOptix ® Toric, Clareon ® Vivity ® Extended Vision Hydrophobic Posterior Chamber IOL and Clareon ® Vivity ® Toric IOLs. Each of these IOLs is indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the Clareon ® Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The Clareon ® PanOptix ® lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. The Clareon ® Vivity ® lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. All of these IOLs are intended for placement in the capsular bag. WARNINGS / PRECAUTIONS: General cautions for all Clareon ® IOLs: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting any IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Physicians should target emmetropia, and ensure that IOL centration is achieved. For the Clareon ® Aspheric Toric, PanOptix ® Toric and Vivity ® Toric IOLs, the lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. For the Clareon ® PanOptix ® IOL, some visual effects may be expected due to the super- position of focused and unfocused multiple images. These may include some perceptions of halos or starbursts, as well as other visual symptoms. As with other multifocal IOLs, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients and may be more prevalent in low lighting conditions. Therefore, patients implanted with multifocal IOLs should exercise caution when driving at night or in poor visibility conditions. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning). As with other multifocal IOLs, patients may need glasses when reading small print or looking at small objects. Poste- rior capsule opacification (PCO), may significantly affect the vision of patients with multifocal IOLs sooner in its progression than patients with monofocal IOLs. For the Clareon ® Vivity ® IOL, most patients implanted with the Vivity ® IOL are likely to experience significant loss of contrast sensitivity as compared to a monofocal IOL. Therefore, it is essential that prospective patients be fully informed of this risk before giving their consent for implantation of the Clareon ® Vivity ® IOL. In addition, patients should be warned that they will need to exercise caution when engaging in activities that require good vision in dimly lit environments, such as driving at night or in poor visibility conditions, especially in the presence of oncoming traffic. It is possible to experience very bothersome visual distur- bances, significant enough that the patient could request explant of the IOL. In the parent AcrySof ® IQ Vivity ® IOL clinical study, 1% to 2% of AcrySof ® IQ Vivity ® IOL patients reported very bothersome starbursts, halos, blurred vision, or dark area visual disturbances; however, no explants were reported. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with these IOLs. ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions. REFERENCES: 1. Market Scope 2023 Premium Cataract Surgery. 2 Alcon, Data on File, 2022. 3. Alcon, Data on file 2024. 4. Oshika T, Fujita Y, Inamura M, Miyata K. Mid-term and long-term clinical assessments of a new 1-piece hydrophobic acrylic IOL with hydroxyethyl methacrylate. J Cataract Refract Surg. 2020 May;46(5):682-687. 5. Maxwell A, Suryakumar R. Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. Clin Ophthalmol. 2018;12:2031-2037. 6. Clareon ® Vivity ® Extended Vision Hydrophobic IOL (CNWET0) Directions for Use – US. 7. Clareon ® PanOptix ® Trifocal Hydrophobic Acrylic IOL Model: CNWTT0 DFU. 8. Lehmann R, Maxwell A, Lubeck DM, Fong R, Walters TR, Fakadej A. Effectiveness and Safety of the Clareon ® Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol. 2021;15:1647-1657. Published 2021 Apr 20. W ith great opportunity in the world of IOLs—there are so many choices available to fit different patient scenarios and visual outcomes—also comes a challenge: how to discuss these options efficiently in a target- ed manner without overwhelming or causing confusion for the patient. EyeWorld spoke with three members of its Cataract Editorial Board to learn how they manage this discussion (multiple times a day) and gain insights on how their pa- tient conversations have evolved over the years. 'It sure does add up' Rosa Braga-Mele, MD Dr. Braga-Mele begins her process of IOL selection and the patient conversation by narrowing down what she needs to focus on based on the patient's eye anatomy. She noted there are several things that could preclude patients from having certain advanced-technology IOLs. "Having said that, my patients are all given a sheet that shares what lenses are available, and it's a broad brushstroke of lenses. Before they even see me, before they get anything done and are sitting in the waiting room, they're reading this list," Dr. Braga-Mele said. "They have time to digest that before they see me, and they may have some questions they want to ask, but if they're eligible for everything, the first question I ask them is do they mind wearing glasses or do they want the opportunity to get rid of glasses for 90–95% of their tasks?" If the patient says they're OK wearing glasses, the con- versation about their lens option can take about 1 minute. If the patient has astigmatism and is willing to pay for the lens, Dr. Braga-Mele said a toric IOL is a "no brainer." "I think the hardest category is the presbyopia-cor- recting lens category because it now becomes halo and glare that you have to discuss with your patient," she said, noting that her conversation with patients interested in presbyopia-correcting IOLs takes about 5 minutes, and they usually require an additional tele-consultation. If the patient is interested in a full range of vision and says they would tolerate halo and glare, Dr. Braga-Mele discusses trifocal options. If they're interested in some range of vision but are less tolerant of halo and glare, she'll discuss EDOF options. She then lets the patient go home and will schedule a phone consultation with them if they want to review the lens options further. Dr. Braga-Mele said her conversation with patients about these options can be revealing as well.

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