Eyeworld

Heading Name title Contact Name: email ASCRS FOUNDATION NEWS ASCRS NEWS by Don Bell ASCRS Foundation Executive Director 8 | EYEWORLD | DECEMBER 2020 "Before surgery, driving was my biggest concern. My cataracts progressed quickly, and I was afraid I would hurt someone. I had to negotiate my hours with my employer to be home before dark or before it started raining. Because my vision was failing, I was often unstable and would fall. I have been given the gift of sight through Operation Sight. I am no longer afraid to drive, try new things, exercise, or just go for a walk. I will use this gift as a platform to make changes in my life and hopefully help someone in return." —Maria, Operation Sight patient S tories like Maria's are received every day through Operation Sight, the ASCRS Foundation's domestic charitable cataract surgery program. They remind us of how critical sight is for independence, stability, and taking care of our families. The past year has been a time of unprecedented challenge for the ASCRS Foundation and the thousands of patients in need it serves. We've struggled, adapted, and found new ways to move forward. I am incredibly proud of our resilient team and the hundreds of volun- teers who've continued to deliver on our mission. I'm hoping that you see yourself in our story. Your steadfast commit- ment in a time of great uncertainty illustrates ophthalmology's resilience and willingness to share its incredible benefits with those less fortunate. When the pandemic first hit, the ASCRS Foundation reached out to its U.S. and international partners to explore how we might best mobilize the power of the ophthalmic community. We used the time to launch a new ASCRS Foundation website, providing a dynamic platform with more detailed information on Foundation programs and volunteer opportunities. We highlighted the work of those who donate their time and talent in hopes of motivating others. Operation Sight has been crucial for patients during the COVID-19 crisis. Between March and October, we saw a 78% increase in applica- tions resulting from the employment, insurance, and economic impacts of the pandemic. The program serves financially vulnerable, uninsured American patients who risk job loss due to decreased vision. Through a network of more than 500 volunteers across the nation, more than 670 charitable surgeries were delivered during that period. During National Sight Week, volunteers "Stepped Up for Sight" by referring colleagues to help eligible patients on our waitlist and delivered the program's 5,000th charitable surgery. Overseas, a lack of PPE at our Robert Sinskey Eye Institute in Addis Ababa, Ethiopia created severe restrictions on its ability to continue serving patients. Working with the Himalayan Cataract Project and an international supplier, we were able to procure the supplies needed to keep the hospital open and continue serving patients. With a focus on international physician training and infrastructure building, we are proud to work with multiple partners to create last- ing change in the fight against global cataract blindness. This summer, Your commitment has made all the difference: A letter to our supporters continued on page 13 ©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.

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