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Contact information Name: by Nathan Radcliffe, MD EyeWorld Glaucoma Editor quite a few large scale prospective clin- ical studies in order to develop a true MIGS algorithm. I am one of many surgeons who has changed his or her XEN 45 gel stent technique in order to get a little more control over postoperative healing and bleb failure. While my new ab externo technique still delivers an efficient and straightforward opera- tion, it isn't quite as streamlined as the original ab interno approach. This new approach gives us a nice example of taking a small step backward from the ideal intraoperative MIGS experience in order to deliver an overall better experience in both the operating room and the clinic for the surgeon and patient. Last year's CyPass withdrawal was, of course, the greatest surprise. Not only did we not see the endothelial problem coming, I think it is safe to say that the field of glaucoma as a whole has much to learn about the corne- al endothelium. We don't even truly know the baseline rate of endothelial cell loss in pseudophakic glaucoma patients. The CyPass withdrawal left us in need of a better understanding of the balance between corneal endothe- lial cells and retinal ganglion cells in patients with glaucoma. My suspicion is that once we know the full impact of traditional glaucoma surgery on the en- dothelium, the CyPass risks will seem more acceptable. In summary, glaucoma continues to be a fascinating and challenging dis- ease, even when we try to "keep things simple" with MIGS. Reference 1. Ahmed IIK, et al. A prospective randomized trial comparing Hydrus and iStent micro-invasive glaucoma glaucoma surgery implants for standalone treatment of open-angle glaucoma: The COMPARE Study. Ophthalmol- ogy. 2019. Epub ahead of print. M ore than a year has passed since we cele- brated the arrival of a nearly complete set of trabecular, supracili- ary, and transscleral MIGS. The future has arrived, but it isn't quite what we thought it would be. In this issue of EyeWorld, we look at four fantastic topics, each of which takes us in a somewhat surprising direc- tion. We discuss MIGS complications, a topic that we thought might not be necessary to discuss. But of course, with growing patient expectations, even the smallest of complications need to be managed adeptly. We look at a data set that certainly should be celebrated: The COMPARE trial, which randomized patients to either two generation one iStents or to the Hydrus—all stand- alone—provided the first large scale comparative MIGS stent data. 1 As you will read, how we use things in the real world is hard to address with a single clinical study. It looks like we will need MIGS continues to surprise ©2019 Ivantis, Inc. Ivantis and Hydrus are registered trademarks of Ivantis, Inc. All rights reserved. IM-0007 Rev C 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 and not head to head comparative studies. JULY 2019 | EYEWORLD | 3 iStent – pg. 40 CyPass placed appropriately – pg. 37 Intraoperative hyphema during insertion of an OMNI Glaucoma Treatment System – pg. 43 With an open conjunctival peritomy, the XEN gel stent position can be easily adjusted after it is injected to ensure proper positioning. – pg. 35 WWW.EYEWORLD.ORG ASCRS JULY 2019 • VOLUME 24, NUMBER 7 FOR SURGEONS. FOR YOU. NEW PREOP OSD ALGORITHM – P. 20 Cover images

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