Eyeworld

by Title Heading Name title Contact Name: email 30 | EYEWORLD | MARCH 2021 ASCRS NEWS ©2021 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. In memoriam John Andrews, MD Died Nov. 24, 2020 Baytown, Texas Marvin Balistocky, MD Died Dec. 18, 2020 Philadelphia, Pennsylvania David Bell, MD Aug. 13, 1942–Feb. 8, 2021 Warsaw, New York Newel Call, MD May 26, 1944–Nov. 19, 2020 Salt Lake City, Utah Steven Civiletto, MD Died Feb. 1, 2021 Greenville, South Carolina Jerry Crum, MD Oct. 19, 1932–Dec. 7, 2020 Roanoke, Virginia Maurice Ehrlich, MD 1936–Jan. 26, 2021 Easton, Pennsylvania Peter Evans, MD Dec. 19, 1925–Dec. 18, 2020 Falls Church, Virginia William Fagman, MD Died January 2021 Long Grove, Illinois Caleb Gonzalez, MD May 1, 1929–Jan. 10, 2021 Lancaster, South Carolina Robert Jampel, MD, PhD Died Nov. 26, 2020 Bloomfield Hills, Michigan Simon Jerrold, MD April 20, 1934–Jan. 5, 2021 Edison, New Jersey Donald Lawler, MD Jan. 6, 1921–Dec. 15, 2020 Columbia, Missouri George Lazenby III, MD Oct. 18, 1934–Dec. 20, 2020 Clearwater, Florida Joshua Litwin, MD Oct. 3, 1959–Nov. 20, 2020 Berkeley, California James Murtagh, MD April 13, 1935–Jan. 8, 2021 Morgan City, Louisiana James Ney, MD Died Dec. 22, 2020 Delavan, Wisconsin Vanessa Ngakeng-Fokam, MD April 15, 1975–Dec. 27, 2020 Atlanta, Georgia Linda Obenour, MD Aug. 8, 1942–Dec. 2, 2020 Lynchburg, Tennessee Thomas O'Malley Sr., MD March 6, 1935–Nov. 27, 2020 Stevens Point, Wisconsin David Parke, MD Nov. 19, 1922–Nov. 13, 2020 North Branford, Connecticut Theodore Pearlman, MD Nov. 3, 1946–Dec. 2, 2020 Freehold, New Jersey Jesse Rigsby III, MD Sept. 1, 1948–Feb. 2, 2021 Iowa City, Illinois Norman Sawyer, MD Jan. 1, 1927–Dec. 27, 2020 Atlanta, Georgia Julian Saxe, MD June 14, 1920–Jan. 17, 2021 Indialantic, Florida Robert Shapiro, MD Died Dec. 24, 2020 Satellite Beach, Florida Robert Thompson, MD April 24, 1934–Dec. 5, 2020 Carlisle, Pennsylvania Karl Ticho 1926–Nov. 25, 2020 Glenview, Illinois Ambrose Updegraff Sept. 20, 1928–Feb. 9, 2021 St. Petersburg, Florida Robert Weiss, MD Died Nov. 24, 2020 Warren, Pennsylvania Robert Welch, MD Died Jan. 5, 2021 Towson, Maryland Henry Zeiter, MD July 31, 1934–Dec. 20, 2020 Stockton, California EyeWorld honors the lives of ophthalmologists who have died recently with recognition in this space. To recognize an ophthalmologist here, send the name, location, post-nominal letters, birth date, and death date to liz@eyeworld.org.

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