Eyeworld

MAY 2020

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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Contact Name: ASCRS NEWS 20 | EYEWORLD | MAY 2020 2017 in which residents were supervised by an anterior segment at- tending with 10 or more years of experience. The authors of this study created a risk stratification score for cataract cases by looking at preop- erative risk factors such as presence of pseudoexfoliation, proliferative diabetic retinopathy, prior vitrectomy, 4+ dense, white or brunescent cataract, current tamsulosin use, pre-existing zonular dialysis, intraoper- ative use of iris hooks, or other pupillary expansion device. This scale was similar to other grading rubrics for cataract surgery risk factors that have been published previously, 2–6 including one study that validated a previously identified scale, 7 and the authors did show that there was a statistically significant difference in complication rate between each category, with complication rates increasing with higher risk categories, providing validation for this scale. Complication rates between the two supervising attending groups were compared in each risk category using clustered logistic regression analysis. The authors found a statistically significant difference in complica- tion rates among simple, intermediate, and complex cases, with complex cases showing the highest complication rates. The authors did not find a statistically significant difference in any risk category among low-, inter- mediate-, and high-risk cases in terms of intraoperative complications between full time and volunteer faculty. Although there was no statisti- cal significance in either category, the study suggests that there did seem to be a higher non-statistically significant rate of intraoperative com- plication in the high-risk category for volunteer attendings. In terms of secondary endpoints, the authors did find a difference between the types of complications seen between full time and volunteer attendings. The authors did not note any statistically significant difference in terms of complication rates for individual attendings during this study. The results show that complication rates increased with increas- ing complexity between cases, as expected, thus adding to the known literature on the fact that increased preoperative risk leads to increased intraoperative complications. 5,8,9 The fact that there was no statistically significant difference in complication rates supports the idea that there was no significant bias in this way between attendings. There was no statistically significant difference in complication rates between volunteer and full time attendings in the three case complexity categories. The authors conclude that volunteer faculty can be safely integrated into residency training programs and would benefit programs by helping increase resident case volume and by exposing res- idents to diverse surgical techniques. The authors point out that while this can be concluded for lower-risk cases, further exploration is needed for intermediate- and high-risk cases as the numbers in both of these categories were small and may not have had adequate power to make any conclusions. This paper has several strengths. The first is that it included 1,377 cases, thereby providing adequate statistical power in lower-risk cases. 10 The second is that it incorporated a grading scale for presumed patient risk prior to cataract surgery. This scale was developed based on prior continued from page 18 continued on page 22 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. †Data on file - includes trabeculectomy and tube shunt. ©2020 Ivantis, Inc. Ivantis and Hydrus are registered trademarks of Ivantis, Inc. All rights reserved. IM-0008 Rev D

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