Eyeworld Supplements

This supplement was produced by EyeWorld and sponsored by Bausch + Lomb. enVista, Trulign, and Crystalens are trademarks of Bausch & Lomb Incorporated or its affiliates. Copyright 2015 ASCRS Ophthalmic Corporation. All rights reserved. The views expressed here do not necessarily reflect those of the editor, editorial board, publisher, or the sponsor and in no way imply endorsement by EyeWorld, ASCRS or APACRS. continued from page 3 Premium vision series 4 Crystalens ® AO Accommodating IOL INDICATIONS FOR USE: The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. The Crystalens provides approximately one diopter of monocular accommodation, which allows for near, intermediate, and distance vision without spectacles. WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient. Some adverse events that have been associated with the implantation of intraocular lenses are: hypopyon, intraocular infection, acute corneal decompensation, and secondary surgical intervention. PRECAUTIONS: Do not resterilize; do not store over 45°C. ATTENTION: Refer to the Physician Labeling for complete prescribing information. TRULIGN ® Toric Posterior Chamber IOL INDICATIONS FOR USE: The TRULIGN Toric Posterior Chamber Intraocular Lens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision. WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient. Some adverse events that have been associated with the implantation of intraocular lenses are: hypopyon, intraocular infection, acute corneal decompensation, and secondary surgical intervention. SAFETY AND PRECAUTIONS: Do not resterilize; do not store over 45°C. ATTENTION: Please see Directions For Use for important safety information. enVista ® Hydrophobic Acrylic IOL The enVista IOL is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag. Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: 1. Severe anterior or posterior segment inflammation or uveitis. 2. Patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases. 3. Surgical difficulties that increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss). 4. Any trauma or developmental defect in which appropriate support of the IOL is not possible. 5. Circumstances that would result in damage to the endothelium during implantation. 6. Suspected microbial infection. 7. Children under the age of 2 years are not suitable candidates. 8. Patients in whom neither the posterior capsule nor zonules are intact enough to provide support. The safety and effectiveness of the enVista IOL have not been substantiated in patients with preexisting ocular conditions and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more these conditions; vitreous loss (significant), anterior chamber bleeding (significant), uncontrollable positive intraocular pressure. Patients with preoperative problems such as corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, transient or persistent glaucoma, and secondary surgical intervention. Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair. For complete storage and handling information and for physician labeling information, refer to the enVista product package insert. The best visual outcomes from the Crystalens AO and TRULIGN toric begin with preop tools and techniques, including preop measurements like macular OCT to check the health of the macula. While changes in the macula would not preclude the use of the lens, you need to let patients know that there may be some limitations. We follow the Bausch + Lomb guidelines for IOL power correction. That means for the majority of patients we use the SRK/T formula. But for small eyes of axial lengths less than 22 we use Holladay II, and for cor- neal curvature either more than 47 D or less than 42 D, we also use Holladay II. I always try to do the dominant eye first, targeting from plano to minus a quarter. We can usually hit that, and it is good for our patients who want to be able to drive right away. For the power in the non-dominant eye, I look at the eye we have already treated, put some plus lenses in front of it, and see how much they need to see J2. Then I will use that to find what lens overcorrection I want in the second eye. If they already see J2 or J3 in the dominant eye, I will again go for plano to –0.25 D in the non-dominant eye, as binocularly they will usually see one line better up close. Key surgical points include the need for polishing the anterior and posterior capsule; rotating the lens at least 180 degrees; and ensuring complete wound closure to prevent even micro wound leaks that could compro- mise the positioning of the lens implant. As long as you are willing to do a little extra work in a small percentage of patients, the majority of patients should be very happy with the extended range of vision offered by these lenses. Dr. Whitman is chief surgeon at Key-Whitman Eye Center in Dallas. He can be contacted at whitman@keywhitman.com. References 1. Johansson B, Sundelin S, Wikberg-Matsson A, et al. Visual and optical performance of the Akreos ® Adapt Advanced Optics and Tecnis Z9000 intraocular lenses: Swedish multicenter study. J Cataract Refract Surg. 2007;33:1565–72. 2. Pepose JS, Qazi MA, Edwards KH, et al. Compar- ison of contrast sensitivity, depth of field and ocular wavefront aberrations in eyes with an IOL with zero versus positive spherical aberration. Graefe's Arch Clin Exp Ophthalmol. 2009;247:965–73. 3. Packer M, Rajan M, Ligabue E. Clinical properties of a novel, glistening-free, single-piece, hydrophobic acrylic IOL. Clin Ophthalmol. 2014;8:421–7. 4. Xi L, Liu Y, Zhao F, Chen C, Cheng B. Analysis of glistenings in hydrophobic acrylic intraocular lenses on visual performance. Int J Ophthalmol. 2014;7:446–51. 5. Dhaliwal DK, Mamalis N, Olson RJ, et al. Visual sig- nificance of glistenings seen in the AcrySof intraocular lens. J Cataract Refract Surg. 1996;22:452–7. 6. Bausch & Lomb Incorporated Study #658. "A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of a Bausch + Lomb One Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction." Final Clinical Study Report, Aug. 24, 2011. 7. Heiner P, Ligabue E, Fan A, et al. Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista ® )—results of a European and Asian-Pacific study. Clin Ophthalmol. 2014;8:629–35. 8. Data on file, Bausch & Lomb Incorporated. Study 650. 9. Pepose JS, Qazi MA, Davies J, Doane JF, Loden JC, Sivalingham V, Mahmoud AM. Visual performance of patients with bilateral vs. combination Crystalens, ReZoom, and ReSTOR intraocular lens implants. Am J Ophthalmol. 2007;144(3):347–357. SUR/EVA/15/0017

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