Glaucoma
July 2021
by Liz Hillman
Editorial Co-Director
Some MIGS options are approved (and thus insurance covered) only in conjunction with cataract surgery, while others are not limited in this way. Three ophthalmologists EyeWorld spoke with think there is a value in uncoupling some MIGS procedures from cataract surgery, yet two of the three do not perform off-label standalone MIGS, which we’re defining here as those approved without cataract surgery.
“We should be able to find what is right for the patient—what is the best safety, efficacy, and cost. What does the best balance look like for each particular patient?”
Larissa Camejo, MD
“We should be able to find what is right for the patient—what is the best safety, efficacy, and cost,” said Larissa Camejo, MD. “What does the best balance look like for each particular patient? I can think of some patients where it might make sense to do an angle procedure or MIGS where you might want to do a standalone that is currently approved only with cataract surgery, and they might benefit from that vs. doing something more extensive.”
What are the barriers?
Robert Noecker, MD, said the barriers to standalone MIGS are multifaceted.
One barrier is history. iStent (Glaukos) was approved in conjunction with cataract surgery, and as the first modern MIGS, as he described it, a lot of surgeons naturally began using it. This combination with cataract surgery continued with the approval of Hydrus (Ivantis) and CyPass (Alcon), prior to the latter being withdrawn from the market.
In general, it makes sense to combine with cataract surgery because the procedure as a whole benefits glaucoma, Dr. Noecker said.
“Studies have shown that cataract surgery alone is beneficial to glaucoma patients, but the combination of doing it with an angle procedure or a stent is incrementally helpful for IOP control. I think that’s part of why these procedures are tied to cataract surgery because it is a good thing to take out the lens in terms of opening the angle more and stabilizing it, preventing future peripheral anterior synechiae formation or intermittent angle closure as the lens grows,” he said.
Another reason is the payer.
“[The payer] sometimes allows a trabecular bypass stent as a standalone procedure, but more often they force the algorithm,” Dr. Noecker said. Performing the stent procedure in combination with cataract surgery is the only possible scenario for its use.
Michael Pokabla, DO, said he thinks insurance is the biggest barrier. Patients in the MIGS age demographic are often on fixed incomes and unable to afford an out-of-pocket expense like this, he said. What’s more, there is always the risk of a complication, and then “you might not have a foot to stand on.”
Finally, there is the data. The data for modern, angle-based MIGS is for the most part in conjunction with cataract surgery, while other options that are in the MIGS category but not combined with cataract surgery have long-term data without being a combination procedure.
“Working against the standard of care and the lack of studies to support it is a very difficult barrier,” Dr. Pokabla said.
Who would benefit?
When talking about situations for standalone MIGS, Dr. Camejo said we’re not really talking about mainstream cases. In managing glaucoma, there are so many minutiae, she said.
There are cases where the patient is phakic without a cataract or already pseudophakic and you want to get them off one drop or offer better control, and an angle-based MIGS could achieve that, Dr. Camejo said. On the flip side, there are more advanced glaucoma cases where they might already have a tube or a trab but they need more control and they have an angle that could accommodate a Hydrus or iStent.
What if it’s not just about pressure but about reducing a patient’s drops due to ocular surface issues?
“Intolerance to what you have to keep them on should be equally important. This is something they have to deal with for the rest of their life. That needs to be prioritized much more than what is being done nowadays,” she said.
Despite seeing a benefit of a standalone MIGS in cases like these, Dr. Camejo said she isn’t using them off-label. She said she is often using the XEN Gel Stent (Allergan) and the Omni Surgical System (Sight Sciences) for these cases.
Another type of patient who might benefit from a standalone MIGS is one who lives far from the physician, Dr. Pokabla said.
“Where I live, we see patients from 3 hours away, so to have some of these [more invasive] procedures, it’s very difficult for them to do the tedious follow-up required,” he said.
Another example is a one-eyed patient, Dr. Pokabla said, explaining that more invasive procedures can make vision blurry at first, which is a barrier if a patient only has one eye.
Will angle procedures ever be approved for standalone use?
Dr. Noecker said that XEN leapfrogged to the front of the treatment algorithm for patients who need lower pressures than could be achieved by angle procedures but don’t need or already had cataract surgery. XEN is approved for use without concomitant cataract surgery. He does use iStent and Hydrus off-label in some cases and said on a practical level, there is data coming out that he thinks will favor doing these as standalones.
Dr. Pokabla said he doesn’t think insurance companies will budge in their coverage for standalone MIGS without hard data to support patient safety and efficacy.
“I think they’re smart and watching over the patients, and they want the best things for the patients as well,” he said.
Studies are being published discussing standalone MIGS. A review article several years ago discussed several studies that looked at standalone stent procedures.1 Last year a retrospective study found iStent inject with and without cataract surgery decreased IOP and drops needed 6 months postop.2 Last year, Ivantis released data from its SPECTRUM trial that found standalone Hydrus, which is approved outside of the U.S., resulted in a 30% IOP drop and medication reduction.3
Dr. Pokabla emphasized the importance of physicians tracking and communicating their data for the benefit of their patients.
Who will do standalone MIGS?
If standalone MIGS were to become approved for mainstream use, who would perform the procedures? Dr. Noecker said a majority of MIGS currently are not being done by glaucoma specialists. Cataract specialists often get the “first crack” and see milder glaucoma cases where it’s appropriate to do these kinds of procedures. On the other hand, in cases in which the first MIGS procedure was not sufficient, glaucoma specialists would be more likely to perform them.
Dr. Pokabla thinks the adoption of MIGS procedures by specialty depends on the market. In larger cities, there tends to be more specialization, while ophthalmologists in mid-size and smaller communities are adopting procedures based on patient need, he said.
“These patients don’t like to travel; they’re going to go with the local doctor. … You don’t need to be a glaucoma specialist to do this. This isn’t a skill set problem. People know when patients need very low eye pressure, they send them on to a glaucoma specialist. There is no reason why a general ophthalmologist or cornea or comprehensive ophthalmologist shouldn’t be doing these procedures. It just takes a little time to learn how to navigate through these,” Dr. Pokabla said.
About the physicians
Larissa Camejo, MD
Center for Medical and Surgical Eye Care
Jupiter, Florida
Robert Noecker, MD
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut
Michael Pokabla, DO
Glaucoma Consultants of the Capital Region
Slingerlands, New York
References
- Pillunat LE, et al. Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents. Clin Ophthalmol. 2017;11:1583–1600.
- Silveira Seixas RC, et al. Mid-term evaluation of iStent inject trabecular micro-bypass stent implantation with or without phacoemulsification: A retrospective study. Clin Ophthalmol. 2020;14:4403–4413.
- Ivantis announces 3 year results of Australian SPECTRUM registry for Hydrus Microstent. www.ivantisinc.com/newsroom/ivantis-announces-3-year-results. Accessed Dec. 21, 2020.
Relevant disclosures
Camejo: Sight Sciences
Noecker: Alcon, Allergan, BVI, Glaukos, Ivantis, New World Medical, Nova Eye Medical, Sight Sciences
Pokabla: Allergan, Santen
Contact
Camejo: larissacamejo@mac.com
Noecker: noeckerrj@gmail.com
Pokabla: mjpokabla@yahoo.com
