First-line treatment for glaucoma is typically pharmacologic and aimed at lowering intraocular pressure, which is the only modifiable risk factor to date. However, successful treatment with traditional topical glaucoma medications may be limited by their well-known barriers of adverse effects and poor patient adherence to drop instillation. Tune in to hear Dr. Qi Cui and Dr. Davinder Grover discuss the novel pharmacological therapies and minimally invasive glaucoma surgery procedures that can lower treatment burden and increase compliance.
Advances in Glaucoma Treatment: MIGS (Part 1)
Advances in Glaucoma Treatment: MIGS (Part 1)
Welcome to CME on ReachMD. This episode is part of our MinuteCME curriculum.
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Hi, this is CME on ReachMD, and I’m Davinder Grover. We’re going to talk today about bleb-forming MIGS because they are an option to decrease a patient’s dependency on drops and improve pressure, in patients with glaucoma. We’re going to look at 2 microshunts, the XEN Gel Stent, and the PreserFlo Microshunt. I’m going to start first with the XEN Gel Stent, which has an inner diameter of 45 µm. Now there are a large number of studies on outcomes with XEN. There’s truly too many to kind of overview in just this short episode. But I want to talk first on the the Reitsamer, et al., study, which published 3 years’ data. And it was a retrospective study based in Europe where a mean IOP [intraocular pressure] was 20.7 on 2.5 meds. And at 3 years, they reported a mean IOP of 13.9 on 1.1 meds.
Now most of these patients were of European descent, and they tended to use a lower amount of mito [mitomycin C], which was somewhere between 10 and 20 μg – much lower than other studies. And the needling rate was actually much higher than what’s usually published. Their needling rate was about 43%, where usually the needling rates are around 20%. Now 12.3% of these eyes did require additional glaucoma surgery, but overall at 3 years, the success rate was 65.8% – slightly higher in the XEN alone group, a higher success rate than in the phaco XEN group, but there were no safety concerns. And, as you know, the XEN gel stent can be implanted through a bunch of different techniques. Ab interno, ab externo, with or without a conjunctival peritomy. When you look at all the studies published on those different techniques, the outcomes are actually quite similar for each technique, so I think it really shows that you stick with the technique you’re most comfortable with.
Now when it comes to the PreserFlo Microshunt, this has an inner diameter of 70 µm, and it’s a little bit longer, at 8.5 mm. It’s approved in Europe and in Canada, but not in the United States. The FDA trial is complete, and it was a prospective, randomized, multicenter, interventional trial which showed no significant safety concerns, and both groups had significant decrease in IOP and a decrease in dependence on glaucoma drops. But at 1 year, the probability of success was lower in the microshunt group compared to the trabeculectomy group – 53.9% compared to 72.7%. Now in the microshunt group, the mean IOP decreased from 21.1 mmHg on 3.1 medications to 14.3 on 0.6 meds at 1 year. The trabeculectomy group – their mean IOP decreased from 21.1 mmHg on 3 meds, down to 11.1 on 0.3 meds. So the trial group had a lower overall IOP, but both groups did well. Now the incidence of hypotony was higher in the trabeculectomy group. If this was a noncomparative study, similar to the pivotal trial that got XEN approved, with a 510(k) pathway, I think PreserFlo would have been approved. But it’s just hard to beat trabeculectomy, and that was one of the major endpoints. And because PreserFlo did not beat trabeculectomy, I think that’s one of the reasons it was not approved. And trabeculectomy is hard to study, right? The floor is much lower, so you can get much lower pressures, whereas these microshunts really protect against hypotony, and that’s actually why we like them. Now also with the microshunts, you typically need to get higher dose – you need to use higher doses of mitomycin C, which is was we see in the studies published out of Europe and in Canada. Much higher than it would ever be approved by an FDA trial.
Now overall, you know, I envision these microshunts and these techniques for delivering microshunts to continue to evolve and improve, and while I don’t think we’re there, to say that microshunts should completely replace trabeculectomy, I do envision sometime in the next couple years, once we get even better with these microshunts, to be able to make that statement.
Well, that’s all we have for today. Thank you for joining me.
You have been listening to CME on ReachMD. This activity is provided in partnership with the National Eye Institute of the National Institutes of Health, of the U.S. Department of Health and Human Services along with Prova Education, and is part of our MinuteCME curriculum.
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In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.
Qi Cui, MD, PhD
Assistant Professor of Ophthalmology
University of Pennsylvania
No relevant relationships reported.
Davinder S. Grover, MD, MPH
Glaucoma Specialist, Ophthalmologist
Glaucoma Associates of Texas
Fort Worth, TX
Advisory Board: CATS Tonometer, iSTAR Medical, Sanoculis, Versant Health
Consulting fees: Allergan, New World Medical, Nova Eye Medical, Olleyes, Reichert, Sanoculis
Research: Allergan, New World Medical
- Stephen Chavez has nothing to disclose.
- Cindy Davidson has nothing to disclose.
- Elizabeth Lurwick had nothing to disclose.
- Andrea Mathis has nothing to disclose.
- Colleen Resnick has nothing to disclose.
- Robert Schneider has nothing to disclose.
- Stephanie Wenick, MPhil, has nothing to disclose.
After participating in this educational activity, participants should be better able to:
- Describe topical therapies and sustained-release formulations of antiglaucoma medications that may improve patient adherence
- Recognize minimally invasive glaucoma surgery (MIGS) uses and indications
- Evaluate clinical data of recently approved topical therapies, sustained-release formulations of antiglaucoma medications, and MIGS for patients with early- to moderate-stage glaucoma
- Implement strategies to individualize therapy for patients with early- to moderate-stage glaucoma
This activity is designed to meet the educational needs of ophthalmologists and optometrists.
In support of improving patient care, Global Learning Collaborative (GLC) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
Global Learning Collaborative (GLC) designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Global Learning Collaborative (GLC) designates this activity for 1 nursing contact hour. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
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