The Advent of Standalone MIGS and Opportunities for Patient Engagement

The growth of minimally invasive glaucoma surgery (MIGS) procedures over the past decade has significantly shaped how patients are treated in the clinic. The ability to effectively lower intraocular pressure (IOP) with a procedure that has a favorable safety profile has prompted eyecare providers to actively intervene earlier in the disease process. The reasons are manyfold: emerging evidence suggesting that procedures that restore natural physiologic outflow early in the disease may moderate IOP fluctuations,¹ and the potential to avoid or reduce the risk of needing a secondary (and more invasive) surgical intervention later.²

There is, of course, another benefit that strikes home with patients and physicians: In study after study, MIGS procedures have demonstrated the ability to reduce or eliminate medication burden.^3,4 Eyecare providers understand the benefit of removing poor patient compliance as a factor in consistent disease control, while patients find reducing of the stinging, blurring, and conjunctival hyperemia sometimes associated with topical drops leads to improvements in quality of life. Both parties are happy to be rid of the insult to the ocular surface and all that implies. Thus, it seems logical that optometrists should take a greater role in educating patients about all their treatment options, including surgery when it is warranted.

Now, with the growing need for standalone MIGS (MIGS performed uncoupled from cataract surgery), redefining the role of primary eyecare providers in the glaucoma patient’s treatment journey is even more important. Here, a panel of optometric thought leaders discuss the growth of MIGS procedures, what they mean for patients, and the opportunity for optometrists to help patients achieve better and more meaningful outcomes.

How has MIGS impacted how glaucoma patients are managed?

Nate R. Lighthizer, OD, FAAO: Before MIGS, the treatment of glaucoma was often linear: drops first, followed by laser, and surgery as a last resort—and a lot of conversation was occupied talking about complications and risks associated with trabeculectomy and glaucoma drainage devices. The introduction of safer surgeries that reduce IOP with less reliance on patients’ compliance, that are suitable to use earlier in the disease course, and that might reduce medication burden as an additional benefit, has completely changed how glaucoma patients are managed. MIGS has given rise to the interventional mindset, where we are really talking about procedures with a multitude of benefits. If it was my eye, or my loved one’s eye, instead of taking drops that may be burdensome, I would rather have a safe, efficacious procedure that’s going to save me from all those burdens.

Leslie E. O’Dell, OD, FAAO: What has really changed with MIGS is that it allows us to be proactive in the best interest of the patient. The prospect of trabeculectomy or glaucoma drainage device surgery scares some patients. With MIGS, we have safe and effective options suitable for intervening earlier in the disease process, and that’s a huge win for the patient. Now, when we discuss risks and benefits, we can explain that we may also improve the patient’s ocular surface if we can reduce dependence on drops.

Damon Dierker, OD, FAAO:There are two features of treating glaucoma that have benefited from the growth of the MIGS category. The first is that, with more options at our disposal, we are better positioned to individualize and customize care for the patient. That has always been the goal, but now we have the tools to achieve it. Another benefit of MIGS is that we’ve become better as a field at detecting glaucoma. Our industry partners are continuously introducing improved technology that enables the detection of glaucoma earlier in its disease process and thereby helps us treat patients prior to any visual field damage. The next leap forward will be when we get better at identifying the very earliest signs of glaucomatous progression.

What are the most important things to know about MIGS?

Dr. O’Dell: The opportunity for optometry. The move toward procedural management of glaucoma is a significant shift, and it will take some adjustments in how we educate patients. It’s a tremendous opportunity to embrace the changing paradigm and help connect patients to interventions that will help control their glaucoma, avoid its progression, and have a meaningful impact on their daily lives.

Dr. Dierker: MIGS has really changed the definition of a successful outcome for the patient. With drops, we talk a lot about slowing progression and avoiding IOP elevation. When we discuss MIGS, we are doing the same, but we can also talk about stabilizing the IOP, reducing drops, and the potential to avoid more invasive surgeries in the future. We know that, when combined with cataract surgery, MIGS is an added benefit.³ Now, we can also talk about MIGS in a standalone setting, which brings in patients with mild-to-moderate glaucoma who don’t have a cataract, as well as patients who had cataract surgery previously but whose glaucoma is now progressing. The bottom line is we can do more for our patients with a wider array of options.

Vin T. Dang, OD, FAAO: One of the most important things we can relay to patients is the safety profile associated with MIGS as a class.⁵ A MIGS procedure may require a trip to the OR, but the safety profile associated with MIGS is perhaps its most attractive feature. Safety is a key reason why MIGS is viable in early-stage disease.

Dr. Lighthizer: The safety part of the story is a great way to start the conversation, and then we can start to talk about the effectiveness. As of now, the OMNI Surgical System (Sight Sciences) is one of the only MIGS options that is FDA-cleared or approved for standalone use as a standalone option and in combination with cataract surgery for eyes with mild-to-moderate primary open-angle glaucoma (Figure).^6-9

What, if anything, is different about standalone MIGS with OMNI?

Dr. Dierker:Many of our colleagues still think about MIGS as being cataract surgery plus a stent—some aren’t even aware of the array of canaloplasty, goniotomy, and trabeculotomy options that can be used at the time of cataract surgery. Standalone MIGS with OMNI is a recent innovation in the space, but there are good quality data available showing that good outcomes are achieved whether OMNI is used with cataract surgery or as a standalone procedure.¹⁰

Dr. Lighthizer: Standalone MIGS is simply MIGS uncoupled from cataract surgery. For years, the message to patients has been that if you are getting cataract surgery, you have a one-time opportunity to also address your mild-to-moderate glaucoma. Now we can tell many more patients that they have an opportunity to lower their IOP and reduce their medication usage.

Dr. Dierker: The mechanism of action associated with OMNI is important to mention because it may help to explain why it is so beneficial for early-stage disease, which often affects younger patients before they have a cataract. During the procedure, the surgeon threads a catheter through the Schlemm’s canal, then, following an infusion of fluid, tears the trabecular tissue. Fundamentally, the maneuvers target three areas of potential resistance: the Schlemm canal, the trabecular meshwork, and the distal collector channels. That’s important because, while resistance in the trabecular meshwork is important in primary open-angle glaucoma, resistance in other parts of the pathway, including the Schlemm canal, are also crucial.^11,12 There is also an emerging understanding of how blockage of the distal collector channels affects the ability to maintain stable IOP.¹³ Taken together, the OMNI procedure addresses the underlying factors that lead to pressure elevations, and in the hands of surgeons, OMNI is an option that can be tailored to the needs of the patient.

Dr. Lighthizer: The fact is we cannot know where the resistance is in an eye with primary open-angle glaucoma. We can target treatment to the trabecular meshwork with selective laser trabeculoplasty (SLT) or surgically with a stent, but that only treats one area. In fact, if your patient has had an SLT or a stent placed and the pressure doesn’t respond, that’s probably an indication that the aqueous pathway is blocked somewhere other than the trabecular meshwork. Those patients would be good candidates for a procedure like OMNI.

Dr. Dang: The multiple mechanisms of action associated with OMNI are interesting. There is ongoing research that will help us understand the impact of addressing three points of potential resistance within the aqueous drainage pathway. I suspect we may learn that resetting the anatomy, particularly early in the disease process, may have long-term implications for better disease control, lower drop burden, and greater avoidance of secondary surgical intervention. In the meantime, because of what I know about its mechanism, I am confident discussing OMNI with my patients, and because of what I see in the data, I know my patients will benefit from the procedure, either in combination with cataract surgery or as a standalone option.

How can optometrists take a larger role in connecting patients with MIGS options?

Dr. O’Dell: My sense is that a lot of patients are simply unaware of MIGS, and so they may be suffering in silence thinking there is nothing they can do about their drops. It is simple to direct a few questions about drop compliance and their experience with medications. Some patients will shut down at the mention of surgery, but we can focus on the minimally invasive aspect, talk about the safety, and then discuss the effectiveness. We already have those conversations around cataract and refractive surgeries. This is another category of patients where optometrists can take an active role in care management.

Dr. Dang: By and large, patients are looking for solutions. If they have glaucoma, they may be tired of their drops, they may be experiencing ocular surface issues, or it could be the drops aren’t working that well anymore. Letting them know there are other options than drops is important because it builds trust and lays the foundation for more in-depth conversations later.

Dr. Dierker: We can all start by taking the mindset of being proactive and listening to the individual patient’s concerns. Our glaucoma patients are already coming to us for pressure checks and visual fields, which is a great opportunity to identify problems with adherence, compliance, costs, or disease progression. If we can put ourselves in the individual patient’s shoes and really understand the journey that individual is on, we can identify what is meaningful to them in terms of an outcome. That can lead to more effective conversations because you’ve identified a need for the patient based on their experience.

Dr. Lighthizer: We talk about this a lot in optometry, but it bears repeating: effective communication with patients is built on trust, and trust is built up over time. That’s why we make it a point to start laying the foundation about MIGS early in the glaucoma disease process by talking about procedural options as an alternative to, or used in addition to, drops. We plant the seed early so we can have a more fruitful conversation when the time comes.

Dr. Dierker: Glaucoma is a progressive disease that can lead to blindness, and the symptoms of progression aren’t always recognized. That can be a scary proposition for patients to face. Letting patients know about their options early in the disease doesn’t commit them to anything, but it lets them know that we’ve got their best interest in mind and that we’re going to continue to monitor and do the best we can today, but we are ready if the plan changes. It can be incredibly reassuring for the patient to know there are options in reserve if their treatment is not successful for whatever reason.

Can you share some pearls for success?

Dr. Lighthizer: We’ve talked about the role of building trust with the patient. Equally important is having a close partnership with the surgeon. From a practical standpoint, that means being diligent about sending clinical notes and responding to questions. I also think it’s important to be an active participant in the patient’s care—we should feel confident letting our surgeons know we think a particular patient might be a good candidate for MIGS and why.

Dr. Dierker: The optometrist should align with the surgical team, which doesn’t have to be exhaustive. It might just be a quick conversation with the surgeon to make sure you are both on the same page, and then you follow up with the patient to let them know that doing something a little bit more definitive surgically with minimal risk is probably going to be the best option.

Dr. O’Dell: There is some undue concern among optometrists about potentially losing a patient after a referral. Frankly, I think that’s the wrong mindset. We should be more concerned that the patient left because they weren’t able to get the care they needed rather than focusing on losing out on an opportunity to treat them. That said, I don’t think the fear of losing patients should be a significant concern if you have an established relationship with the surgeon.

Dr. Lighthizer: I agree. The idea of losing patients after a referral has not been a factor in the context of ocular surface disease patients managed by different specialists, and it hasn’t been a deterrent in the collaborative care of cataract and refractive patients. Why should it be any different with glaucoma patients? I will add that it is fair game to consider where the patient is being referred. I have the benefit of working closely with surgeons who offer a lot of different options for glaucoma, and so I know my patients will be in good hands when I send them for a consultation. We have built trust over time, so it never even enters my thinking that I might lose the patients. In fact, a lot of patients we send for a MIGS procedure come back to us off drops and extremely happy to continue being monitored two to four times a year.

Final Thoughts

Dr. Dierker: The MIGS space has evolved quickly and it’s not slowing down. As optometrists, we should embrace our role in the evolving glaucoma treatment landscape, because the expanding category of MIGS means more ways to help patients achieve a meaningful outcome. To be effective in doing that, it will be incumbent on each of us to stay aware of the latest developments so we can effectively communicate with patients.

Dr. Lighthizer: This concept of interventional glaucoma is here to stay. Patients are expressing interest in options to get off drops, and if we can help steer them to options that do that while addressing a quality-of-life issue in the process, that is a win all around. I don’t know how practitioners can’t be excited about the multitude of benefits MIGS offers to patients, and with the viability of standalone MIGS with OMNI, we can now talk about those benefits with a greater number of patients.

Dr. Dang: Standalone MIGS has the potential to shift referral patterns. We may see some of our colleagues in the anterior surgery space start offering these kinds of procedures. It may be that the glaucoma specialists’ role shifts to the management of more complicated cases. But as these things change, the one constant will be a need to identify candidates in the community, preferably early in the disease process, and share with them relevant education about their options.

Dr. O’Dell: While extending the availability of MIGS to standalone procedures may seem a minor development, it is in fact significant when you think about the millions of patients post-cataract surgery now experiencing progression of their glaucoma, as well as the countless patients being diagnosed with early-stage glaucoma. The tools are out there to help our patients achieve a better outcome. We need to be aware of them so we can be a resource for our patients who are struggling on their drops or otherwise experiencing glaucomatous progression and the risk of permanent vision loss.

© 2022 Sight Sciences, Inc. 11/22 OM-2682-US.v1

Sight Sciences and OMNI are registered trademarks of Sight Sciences.

IMPORTANT SAFETY INFORMATION

Indications for Use

The OMNI® Surgical System is indicated for canaloplasty (micro-catheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Contraindications

Do not use the OMNI® in any situations where the iridocorneal angle is compromised or has been damaged (e.g., from trauma or surgery), since it may not be possible to visualize the angle or to properly pass the microcatheter.

Do not use the OMNI® in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris.

Do not use the OMNI® Surgical System in quadrants with previous MIGS implants.

Please refer to the full Instructions For Use, available at omnisurgical.com, for warnings, precautions, and adverse event information.