Eyeworld

ATARACT C 38 | EYEWORLD | OCTOBER 2020 ©2020 Ivantis, Inc. Ivantis and Hydrus are registered trademarks of Ivantis, Inc. All rights reserved. IM- 0070 Rev A CAUTION: Federal law restricts this device to sale by or on the order of a physician. INDICATIONS FOR USE: The Hydrus Microstent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG). CONTRAINDICATIONS: The Hydrus Microstent is contraindicated under the following circumstances or conditions: (1) In eyes with angle closure glaucoma; and (2) In eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber (AC) angle. WARNINGS: Clear media for adequate visualization is required. Conditions such as corneal haze, corneal opacity or other conditions may inhibit gonioscopic view of the intended implant location. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, peripheral anterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard. PRECAUTIONS: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the Hydrus Microstent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, eyes with significant prior trauma, eyes with abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, eyes with preexisting pseudophakia, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open angle glaucoma, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes that have undergone argon laser trabeculoplasty (ALT), eyes with unmedicated IOP < 22 mm Hg or > 34 mm Hg, eyes with medicated IOP > 31 mm Hg, eyes requiring > 4 ocular hypotensive medications prior to surgery, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment and when implantation is without concomitant cataract surgery with IOL implantation. The safety and effectiveness of use of more than a single Hydrus Microstent has not been established. ADVERSE EVENTS: Common post-operative adverse events reported in the randomized pivotal trial included partial or complete device obstruction (7.3%); worsening in visual field MD by > 2.5 dB compared with preoperative (4.3% vs 5.3% for cataract surgery alone); device malposition (1.4%); and BCVA loss of ≥ 2 ETDRS lines ≥ 3 months (1.4% vs 1.6% for cataract surgery alone). For additional adverse event information, please refer to the Instructions for Use. MRI INFORMATION: The Hydrus Microstent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified conditions. Please see the Instructions for Use for complete product information. References: 1. Samuelson TW, Chang DF, Marquis R, et al; HORIZON Investigators. A Schlemm canal microstent for intraocular pressure reduction in primary open-angle glaucoma and cataract: The HORIZON Study. Ophthalmology. 2019;126:29-37. 2. Vold S, Ahmed II, Craven ER, et al; CyPass Study Group. Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open- Angle Glaucoma and Cataracts. Ophthalmology. 2016;123(10):2103- 2112. 3. US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Glaukos iStent® Trabecular Micro-Bypass Stent. US Food and Drug Administration website. https://www. accessdata.fda.gov/cdrh_docs/pdf8/P080030B.pdf. Published June 25, 2012. 4. US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): iStent inject Trabecular Micro-Bypass System. US Food and Drug Administration website. https://www. accessdata.fda.gov/cdrh_docs/pdf17/P170043b. pdf. Published June 21, 2018. *Comparison based on results from individual pivotal trials (of those devices for which pivotal trials are available) and their respective controls and not head to head comparative studies. Other MIGS treatments have not been tested in pivotal trials. †Data on file – Compared to control and includes trabeculectomy and tube shunt. Combination considerations William Trattler, MD, however, thinks that both an NSAID and ste- roid are helpful for cataract patients. "I find that corneal swelling after cataract surgery is quite frustrating for patients who expect rapid visual recovery. Topical steroids help prevent and treat corneal edema. Topical NSAIDs are critical, too, as they help keep the pupil large during cat- aract surgery, reduce intraoperative and postop pain, and help prevent CME. So including both a steroid and NSAID in and around cataract surgery provides faster visual recovery and a better intraoperative and postoperative experience for patients," Dr. Trattler said. He starts both agents 3 days preop. In his view, an NSAID alone is insufficient, and it would also be a mistake to use only a steroid with cataract surgery. "If you only use ste- roids, then you're going to be in real trouble as far as CME," Dr. Trattler said. He cited the Wittpenn study, which showed that when patients were randomized to receive either a steroid plus an NSAID or steroid alone, those that received the combination had less swelling of the macula on OCT. 3 "Since then, many have confirmed that these topical NSAIDs are synergistic with steroids," Dr. Trattler said. Steroid alone Kevin M. Miller, MD, uses an antibiotic and prednisolone alone for standard cataract surgery. He views nonsteroidal agents as having a benefit to a small subsection of the population. "There are all kinds of costs and toxicity associated with nonsteroidals," Dr. Miller said, adding that he reserves the NSAIDs for high-risk patients, such as those with retinitis pigmentosa or diabetic macular edema. "If you look at the literature, it's 1–2% of routine uncomplicated cataract surgery patients who suffer from postoperative macular edema," he said. "If you treat everyone with a nonsteroidal, you will treat 100 people for the sake of one or two." If Dr. Miller finds patients do have CME, he puts them on a regi- men of an NSAID and prednisolone, both 4 times a day until the ede- ma is gone. "We usually taper them off the nonsteroidal first because it's irritating, then we'll taper them off the steroid," he said. Currently, deciding the best approach means weighing all of these considerations and deciding which best suits a given patient. The doctors here stressed that performing the cleanest surgery possible can get patients off to a promising start. Contact Miller: kmiller@ucla.edu Trattler: wtrattler@gmail.com Walter: kwalter@wakehealth.edu continued from page 36

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