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Gel stent similarly effective with, without cataract surgery
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The Xen gel stent showed similar safety and efficacy in a study involving patients with pseudoexfoliative glaucoma and primary open angle glaucoma as both a standalone procedure and when combined with cataract surgery.
Study subjects underwent surgery with Allergan’s Xen gel stent to treat primary open angle glaucoma (POAG), pseudoexfoliative glaucoma (PEXG), uncontrolled or unstable IOP, glaucoma that progressed with maximum medical therapy and/or intolerance to topical IOP agents.
This prospective interventional study involved 93 eyes of 73 elderly patients, mostly female, who had 24-month follow-up data or had additional surgery during that time. Patients had nine postoperative follow-up appointments at day 1, 3 and 7 and months 1, 3, 6, 12, 18 and 24. Refraction, Goldmann applanation tonometry, anterior chamber slit lamp exam and gonioscopy were performed.
The authors said they defined success as IOP of no more than 16 mm Hg with no concomitant IOP-lowering medications at 24 months. Qualified success was considered as attaining that IOP goal with or without medications.
Over the course of the study, mean medications dropped from 1.9 ± 1.6 in POAG patients to 0.6 ± 0.9 and from 2.0 ± 1.3 in PEXG patients to 0.4 ± 0.7 (P = 29).
With the 16 mm Hg target, 51.4% of eyes with POAG and 57.1% of eyes with PEXG achieved complete success (P = .70) at 2 years. By 24 months, 42.8% of POAG eyes and 43.2% of PEXG eyes (P = .64) underwent needling. A total of 28 ocular adverse events were seen in 30.6% of POAG eyes and 36.4% of PEXG eyes (P = .66), and 14.3% of POAG eyes and 15.9% of PEXG eyes (P = .89) needed additional glaucoma surgery. Adverse events included hyphema, hypotony and blood in the stent.
The authors said they saw greater IOP lowering with the Xen gel stent in PEXG than POAG in the first 12 months, but that the IOP equalized later. – by Nancy Hemphill, ELS, FAAO
Disclosure: Gillman reported no relevant financial disclosures. Please see the full study for all other authors’ disclosures.
Perspective
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Lisa M. Young, OD, FAAO
Every time I turn around there is something new to learn about MIGS. These minimally invasive and conjunctival sparing procedures offer us the opportunity to lower IOP with a relatively simple postoperative course and rapid visual recovery. We utilize many different MIGS procedures in our office, and I have had the opportunity to see some shine, while others have unfortunately faltered.
FDA-approved in late 2016, the Xen gel stent offers an ab-interno approach into the subconjunctival space. Gillman and colleagues have found that this procedure is equally effective when combined with cataract surgery or as a standalone procedure for both POAG and PEXG. Interestingly, their data showed that while PEXG showed a better response to the procedure in the first 12 months, IOP at the 24-month mark was statistically similar between POAG and PEXG.
As I have said before, there are many horses in this race. While Xen isn’t a MIGS procedure that we currently offer, it certainly seems to be in the running as a procedure that may cross the finish line. But, of course, only time will tell.
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