Eyeworld

N Contact information Name: Name: EWS 36 | EYEWORLD | APRIL 2019 Comparing outcomes Investigators found that at the 8-week out- come visit all three treatments improved macular edema, Dr. Thorne reported. "All three were effective at reducing macular edema from baseline, but when we looked at the proportion of improvement, both intravitreal triamcinolone and intravitre- al dexamethasone were more effective than periocular triamcinolone at 8 weeks. Additionally, the dexamethasone implant was non-inferior to intravitreal triamcin- olone in the reduction of uveitic macular edema." The intravitreal approaches were also more effective in terms of secondary out- comes including 20% or greater reduction in macular edema, resolution of macular edema, and proportion of improvement of BCVA. "All of those outcomes sup- ported the primary outcome," Dr. Thorne said. From a visual perspective, all the patients improved. When investigators analyzed the data on each treatment group, they saw an improvement in BCVA from baseline. Once again all three were effective options, however, there were ©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. some differences. "The periocular group at 8 weeks improved by about one line of vision, and the intravitreal groups improved another line over and above that," she said. While these differences were statistically significant, differences between the two intravitreal groups were not significant. Investigators also found that rates of elevation in eye pressure were essentially similar across the groups, Dr. Thorne reported. "Severe eye pressure rises were uncommon, and no cases of glaucoma surgery occurred," she said, adding, how- ever, that the trial was short. Practical implications Clinically speaking, Dr. Thorne thinks the study results substantiate the idea of using the intravitreal approach when possible. "When the average patient with uveitic macular edema comes in, if you're considering intravitreal versus periocu- lar, this study supports using intravitreal earlier in your treatment regimen rather than going with periocular triamcinolone first," she said. continued from page 34 Intravitreal injection of triamcinolone acetonide in the eye Source: Mara Berrocal, MD

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