Dr. Brown is chief medical officer of Sight Sciences. The Hydrus also was associated with reduced need for glaucoma medication (p = .004); more Hydrus subjects were completely free of such medication by month 12 (p = .0057). “We’re trying different things and seeing what works best,” he notes. The COMPARE study was the first to compare two different MIGS devices in standalone surgery, rather than in combination with phacoemulsification. Minimally-invasive glaucoma surgery is intended to lower intraocular pressure with less tissue disruption than traditional glaucoma surgeries. Saturday & Sunday: 11:00AM–3:00PM. This may be a good place to introduce yourself and your site or include some credits. For patients who undergo cataract surgery, Dr. Craven says he still can’t predict whether or not a trabecular bypass procedure is going to work. Current options include canal-based stenting (iStent by Glaukos and Hydrus by Ivantis), viscodilation devices (Omni by Sight Sciences and ABiC by Ellex), excisional goniotomy (Kahook Dual Blade by New World Medical), and a cautery device (Trabectome by MicroSurgical Technology). They found that the Hydrus resulted in a higher rate of surgical success and less need for glaucoma medication. “Often, when surgeons are adept at many of these techniques, it comes down to economics,” says Dr. Kahook. M inimally-invasive glaucoma surgery is intended to lower intraocular pressure with less tissue disruption than traditional glaucoma surgeries. Mean medication burden decreased by 82 percent to 0.55 ±0.79 (p<0.0001), and 61 percent of eyes were medication-free. “Some surgeons might prefer the iStent inject because it’s a ‘stealth’ device and the least-tissue-disruptive canal intervention.”, The concept that might favor an iStent approach: you put in two minimally tissue- disruptive, extremely focal stents, leaving 98 percent of the canal normal, but improved from the phaco effect. The Hydrus Microstent – delivering a new confidence in the treatment of mild to moderate primary open-angle glaucoma: Glaucoma drop elimination Clinically proven, 4-year outcomes showing continued benefit for elimination of glaucoma medication . It should also be noted that the ambulatory surgery center facility fee for some Category I code procedures is not as high as the device intensive codes that are currently coupled with 0191T devices. The study groups were well matched in terms of baseline demographics, glaucoma status, medication use, and baseline IOP. 123 Main Street Dr. Kahook receives royalties from and consults for Alcon, New World Medical and J&J Vision. Second-generation trabecular micro-bypass stents as standalone treatment for glaucoma: A 36-month prospective study. Sutie F 3-year HORIZON results. The prospective HORIZON trial, sponsored by Ivantis, analyzed the Hydrus device when used in conjunction with cataract surgery, with cataract surgery alone used as a control. Safety measures included frequency of surgical complications, changes in VA, abnormal slit-lamp findings, and adverse events. Dr. Seibold is a consultant for New World Medical and Allergan, and has received research support from Alcon and Glaukos. • An overall safety profile that was similar to cataract surgery alone.3. Their pressures come down, and everybody’s happy, but we don’t know how much of the pressure lowering is from the minimally-invasive glaucoma surgery and how much is from removing the cataract. It’s clear to me that each company is trying to position its device based on safety and efficacy; however, the economics of the space (device cost and reimbursement) is also playing a major role that may be underrepresented in many of our discussions at meetings and in trade journals.”. “In the Hydrus, we’re manipulating 8 mm of the canal in a very important region,” “As a result, there could be some fibrosis over time that might not occur with a very stealthy implantation like the iStent inject, which is very tissue-friendly and maintains the normal architecture of the canal as much as possible. Your email address will not be published. We’re trying to find out how to use what we have—and we have the most options that we’ve ever had, by far. With a variety of options—and mechanisms of action—to choose from ophthalmologists can sometimes be hard-pressed to make sense of it all. Download PDF. (310) 482-1240. There’s room for more than one canal device, just as we have multiple IOL platforms and phaco machines. I choose it because I’ve had the most experience with it and it works best in my hands,” he explains. “Now, there are a dozen different approaches and a growing body of evidence for most of the devices we use today. “That’s a lot of work and explanation to patients for a relatively small change in pressure. Dr. Brown emphasizes that now the various approved options are being tested. “I choose angle procedures when I want low to mid-teen IOP and for patients in whom the major goal is decreasing their dependence on medications. First, it provides a direct inlet into the canal because the tail end of the Hydrus resides in the anterior chamber. The data clearly show that cataract surgery alone improves physiologic function, so one might argue that it makes sense to disrupt the tissue as little as possible while augmenting outflow. I like the Hydrus, and I’ve implanted it on many continents. You can use it in different disease severities. Eyes with a preoperative IOP >21 mmHg were significantly more likely to undergo reoperation (p=0.038). (Glaukos funded the article processing and provided writing assistance for the study.). “The data from the device studies show 1.6 and 2.2 as the delta vs. cataract surgery,” he says. The advantage of Hydrus is the tri-modal mechanism. Two iStent inject stents were implanted in 44 consecutive eyes (POAG=38, PXG=4, appositional NAG=1, secondary neovascular glaucoma=1) of 31 patients, and 33 eyes had 36-month follow-up data. 9001 Wilshire Blvd. At three years postop, the mean IOP was reduced by 42 percent to 14.6 ±2.0 mmHg (p<0.0001) and 87.9 percent of eyes achieved an IOP reduction of ≥ 20 percent. “If the Hydrus did better than the single iStent, that shouldn’t be a surprise; the Hydrus accesses at least 90 degrees of the canal, so its odds of accessing one or more outflow channels is much greater. The study included 556 patients and spanned 38 centers in nine countries. Copyright © 2020 Jobson Medical Information LLC unless otherwise noted. Hengerer FH, Auffarth GU, Riffel C, et al. In the future, that might be an option for us, but in the meantime, we’re left with having to remove the trabecular meshwork either through a goniotomy with some kind of a blade procedure or ab interno trabeculectomy with a catheter. Clin Ophthalmol 2019;13:2369. hypothesized that a single Hydrus microstent would result in lower intraocular pressure (IOP) and reduced need for glaucoma medication in patients with open-angle glaucoma (OAG) compared to a pair of iStent devices. All eyes underwent ab interno iStent inject implantation as a sole procedure. But, I’m a MIGS optimist, so I still will use a device or do an Omni in essentially every case in which I’m doing cataract surgery on a patient who’s on glaucoma drugs. Hydrus vs iStent. It’s certainly a quality-of-life boost. Hydrus to the iStent used the original iStent, not the iStent inject. 1. Monday—Friday: 9:00AM–5:00PM “I like the bypass procedure better than an extirpation procedure and combination procedures because, to me, the meshwork might hold some mechanism of action in IOP reduction,” he says. Postop, mean IOP was 14.9 mmHg, 13.9 mmHg, 14.1 mmHg, 14.4 mmHg, and 14.7 mmHg at one, three, six, nine and 12 months follow-up, respectively (all p<0.004). “I had a chance to do that in Saudi Arabia where it’s approved. Westlake Village, CA 91361 3. Dr. Seibold believes that MIGS procedures will gain popularity. I’ve probably done 100 of them post-approval here. Two eyes treated with Hydrus and one treated with iStent had BCVA loss of 2 lines or more. 31824 Village Center Rd. “I use the Dual Blade for my angle procedures, and sometimes combine it with endocyclophotocoagulation, which I consider a minimally invasive approach. There were no serious complications at any time point in the follow-up period. However, hospital-based facility fees are relatively uniform across most angle procedures regardless of type. Also, residency programs are increasingly training residents in MIGS, so new ophthalmologists are coming out of training more comfortable with doing an angle-based or MIGS procedure,” he adds. Beverly Hills CA, 90211 “For people who aren’t undergoing cataract surgery, but who have elevated IOP and for whom medications aren’t working, I look at their age, refractive status, angle anatomy and ocular history,” he says. Study eyes were assigned randomly (1:1) to undergo standalone microinvasive glaucoma surgery (MIGS) consisting of one Hydrus or two iStents. Ahmed et al. Half of the eyes had a history of prior glaucoma surgery. All rights reserved. Third, it also tensions the canal tissue, improving physiological outflow.” According to Dr. Crandall, a recent trial that compared the Hydrus to the iStent used the original iStent, not the iStent inject. According to E. Randy Craven, MD, associate professor and director of the Wilmer Eye Institute, Johns Hopkins Medicine satellite office in Bethesda, Maryland, when evaluating glaucoma patients, ophthalmologists first need to consider whether or not they’ll be undergoing cataract surgery. “I think the innovation represented by these new devices and procedures has sort of outstripped our ability to fully assess the effects of each one,” says Leonard K. Seibold, MD, an associate professor of ophthalmology at the University of Colorado School of Medicine. It’s a fairly straightforward procedure to teach my fellows. Atlanta’s Reay Brown, MD, says he’ll use devices or other approaches when appropriate. “Ultimately, the device that surgeons favor may depend on what long-term data shows in a large population of patients.”, Conclusion “iStent inject is to be seen even easier than the Hydrus. A different study looked at the Kahook Dual Blade. Journal Highlights. The retrospective study from Texas included 111 eyes of 90 patients who underwent KDB goniotomy from January to November 2016. Second, the main body of the Hydrus, the remaining 7 mm or so, sits within the canal, maintaining its patency. Monday—Friday: 9:00AM–5:00PM The safety profiles of the two devices were similar. “Glaukos and others are developing suprachoroidal stents, so I think we’ll see the suprachoroidal pathway come back as another option,” he says. “It’s very empirical. The three-year data from the study found: • 73 percent of Hydrus Microstent patients remained medication-free, compared to 48 percent in the cataract-only arm; • Among patients who entered the study on one medication, 81 percent were medication-free, compared to 48 percent in the cataract-only arm; • Only 0.6 percent of Hydrus patients went on to have invasive glaucoma surgery, compared to 3.9 percent in the cataract-only arm, an 85-percent reduction. Address: Category I codes, used for goniotomy (65820) or viscocanalostomy (66174), have more consistent reimbursement numbers. He adds that the value proposition for all angle-based procedures is enhanced safety compared to full-thickness procedures. The authors acknowledged the limitations of unmasked postoperative examinations but conclude that these findings suggest that trabecular MIGS devices may play an important role in managing IOP and reducing the need for hypotensive medication. Complete surgical success was defined as freedom from repeat glaucoma surgery, IOP ≤18 mm Hg, and no need for glaucoma medication. Conclusion The Hydrus has a lot of potential,” says Dr. Samuelson. Since the evidence of the iStent inject is attaining better outflow via improved access to the collector channels, surgeons may wonder about the relative merits of the iStent inject compared to the Hydrus, which should provide even greater access to the channels, at least in theory. Outcomes of interest were between- and within-group differences in IOP and number of glaucoma medications at 12 months.
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