ASCRS 2023: Study of standalone multiple trabecular micro-bypass stents for uncontrolled glaucoma

Ike Ahmed, MD, sat down with David Hutton, Managing Editor, Ophthalmology Times®, to discuss his presentation on the study of standalone multiple trabecular micro-bypass stents for uncontrolled glaucoma at the ASCRS annual meeting in San Diego

Video transcript

Editor’s note: This transcript has been edited for clarity.

David Hutton:

I'm David Hutton of Ophthalmology Times, the American Society of Cataract and Refractive Surgery is holding its annual conference in San Diego. Joining me today is Dr. Ike Ahmed who is presenting "Prospective Study of Standalone Multiple Trabecular Micro-Bypass Stents for Uncontrolled Glaucoma." Thanks a lot for joining us today. Tell us about your presentation.

Ike Ahmed, MD:

Thank you so much. Well, yes, I'm happy to present this study, which actually was an FDA pivotal study looking at multiple eye stents with the infinite injector, which are three stents in one injector. You know, we've used the MiGs and iStents in combination for cataract surgery for a number of years.

And the standalone indication is still something that's evolving, and this study shed some light on the results using this device in those standalone patients. This patient group was a difficult patient group. These are patients who are defined as refractory glaucoma, people who had failed previous surgery or were on MTMT.

Majority of patients in this study were failed surgeries. These patients were standalone they had three implants placed, and then were followed postoperatively for one year. The result of the study here, we're primarily looking at 20% reduction of IOP, with or without, the same medications that were used before surgery. And also looking at some other metrics like safety as well. And looking, of course, at durable IOP changes from baseline to 12 months as well.

Now this patient population consisted of 70 patients, 61 of them were failed surgery, on average had failed 1.6 procedures already. Many of the patients had moderate to advanced disease, and were not typical, of course, for the average MiGS patient. The patients that were on MTMT were on average of four or more medications, 11 of those were in that group as well. The primary outcome of 20% reduction was achieved by three-quarters of patients, 76% of patients. And 93% of patients maintained or reduced their medication use, while 53% of patients achieved 30% reduction or greater on the same or less medications on durable IOP. So that's something that I think are reasonable results, particularly for this tough-to-treat patient population. And that's really, I think, what this showed.

Average pressure of 23.5, down to around 16.6 millimeters of mercury. Average medication of 3.1, down to about 2.7. As expected, medications didn't change much, but the IOPs did drop. Pressure targets were in their mid teens, they weren't necessarily the ideal pressure for patient with advanced disease. But for patients in this group that perhaps weren't best served by a bleb at the time, or were looking for a bleb-free alternative, this I think showed some of these reasonable results.

Looking at again, a change in IOP in these results were significantly different between the failed surgery group and the MTMT group The MTMT group, which is probably more where this device will be used eventually, had more favorable results, about a 35% drop, versus about a 20% drop in the failed surgery group. And that also was something similar to what we found during the responder analysis. In terms of looking at 30% reduction, and looking at less than or equal to 18. Those patients that had failed surgery, had a higher pressure and less dropped than those that had MTMT. Still both had drops as well.

And safety wise, the good news was there wasn't any serious, you know, serious adverse events. And so I think the results of the studies show that standalone iStents can lower pressure. This is a tough-to-treat patient group. I don't think the results would indicate that this is something to be widely used necessarily in this group.

But I think they show that they can have a role. And particularly we're interested and excited in patients maybe who are earlier in the treatment paradigm. Patients who are more mild to moderate, patients who are more on the MTMT group and patients who aren't necessarily advanced glaucoma which I think are more difficult to treat. So I think we're on the on the step toward understanding the role of MiGs and iStents in standalone patients. Of course, we need more data and more studies like this to be done to substantiate those ideas