Eyeworld

by Title Contact Name: email Heading Name title by Sumit "Sam" Garg, MD Chief Medical Editor A ny surgeon that states that they have never had a com- plication either: 1) does not operate, or 2) is not telling the truth. Ophthalmic surgery can be humbling. From time to time all surgeons experience challenges in surgery that can sometimes result in suboptimal outcomes or morbidity to our patients. All too often, we as ophthalmic surgeons undervalue the time and intensity of the surgeries we perform. Granted, cataract surgery can be done in 20 minutes or less, but in some cases, it takes longer, and the time spent is some of the most concentrat- ed we have. When discussing cataract surgery with our patients, it is not uncommon for surgeons to try and allay fears of surgery and reassure patients that they will be fine afterward. Part and parcel with this are glossing over the various options of IOLs available to them, the pros and cons of each choice, and the surgical complications. This, in my opinion, undervalues the complexity and intensity of what we do and importantly does not properly meet the requirements of informed consent. Ophthalmic surgery has risks, and it takes us a lifetime of learning to perform and refine these surgeries for our patients. Over the past few years, some of our reimbursement cuts to cataract surgery (and other ophthalmic surgery, e.g., MIGS) may be a result of others touting "fast and easy" surgery, which is reflected in the RUC analysis that Medicare uses to set reimbursement rates. Currently, we are at risk of having other MIGS coverage be in jeopardy. In June 2023, five of the seven Medicare Administrative Contractors (MACs) responsible for processing Medicare Part A and Part B medical claims in assigned jurisdictions across the U.S. published a series of "Proposed Local Cov- erage Determinations (LCDs)" on MIGS in what appears to be a well-coordinated effort between the MACs. In these proposed LCDs, the MACs are suggesting that a number of commonly performed procedures including canaloplasty, goniotomy, and cyclophotocoagulation are experimental and investigational in patients over age 18, and they are therefore proposing to cease coverage. It is first important SEPTEMBER 2023 | EYEWORLD | 3 Evaluation, decision making, and surgical skills necessary to provide optimal outcomes © 2023 Alcon Inc. 02/23 US-CLI-2300057 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 dam- aged, 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 superposition of focused and unfocused multiple images. These may include some per- ceptions 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. Posterior 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 disturbances, 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. 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. 2. 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. 3. Clareon ® Vivity ® Extended Vision Hydrophobic IOL (CNWET0) Directions for Use – US. 4. Clareon ® PanOptix ® Trifocal Hydrophobic Acrylic IOL Model: CNWTT0 DFU. 5. 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. continued on page 13

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