Xen gel stent reduces IOP with fewer adverse events than trabeculectomy
Click Here to Manage Email Alerts
MONTEREY, Calif. — Fewer adverse events overall were reported in eyes receiving Allergan’s Xen gel stent to treat glaucoma vs. eyes undergoing trabeculectomy at 12 months in the Gold Standard Pathway Study, according to a poster.
“As surgeons, anytime we consider surgery for a patient, we think about the implications of that surgery for the patient and the health of the eye,” Sahar Bedrood, MD, PhD, told Healio/OSN at the Women in Ophthalmology Summer Symposium, where she presented the data. “I ask myself, how will the patient recover from the surgery? What will their vision be? What is the end goal? And I question if they have any risk factors that would make them have more adverse events.”
In the study, in which 44 eyes with primary open-angle glaucoma were randomly assigned to a trabeculectomy arm and 95 to a gel stent arm, mean reductions in IOP and medication count from baseline were statistically significant at all timepoints in both treatment arms of the overall population (P < .001), with greater IOP lowering demonstrated in the trabeculectomy arm at month 12 (P = .024). Results were similar in medication-free eyes (P = .012).
The difference in ocular adverse events was a secondary endpoint of the study. Overall, 97.9% of those in the gel stent arm and 93.2% of those in the trabeculectomy arm had no surgical complications, while 74.7% of those in the gel stent arm and 93.2% of those in the trabeculectomy arm had at least one adverse event.
“If you look into the relative postoperative adverse events more deeply, the percentage that is amongst the highest is hypotony. There are two types of hypotony, one in which the IOP is low and there are changes to the posterior pole and the vision has declined as a result of it; this is called clinically relevant hypotony. The other type of hypotony is when the IOP is low (in this study, less than 6 mm Hg), but the vision is not affected. This type of hypotony is normal in glaucoma surgery and not considered harmful; in fact, we like seeing it early in surgery because it suggests the surgery is working, as long as the vision is not reduced as a result of it. The clinically relevant hypotony is only 1.1% in the Xen arm and 11.4% in the trab arm,” Bedrood said.
The most common adverse event was reduced visual acuity at any time during follow-up: 38.9% in the gel stent arm and 54.5% in the trabeculectomy arm. This includes at postoperative day 1 when patient vision often is blurry because of patching, use of ointments and potential sutures, Bedrood said.
“Intraoperative and postoperative complications always have to be considered, and the risks and benefits need to be weighed,” Bedrood said. “A large majority of glaucoma patients don’t need their IOP lowered below 12 mm Hg. If they don’t need that, then doing a surgery such as Xen that has fewer potential complications and fewer adverse events can be beneficial to the patient. I often tell patients that the biggest risk with a Xen is that it gets fibrosed and doesn’t work. I can’t say the same for a trabeculectomy.”
Collapse
Bedrood S, et al. Gel stent vs. trabeculectomy: Demographics and medication-free eyes at 12 months in the Gold-Standard Pathway Study (GPS). Presented at: Women in Ophthalmology Summer Symposium; Aug. 25-28, 2022; Monterey, California (hybrid meeting).
Read more about
Click Here to Manage Email Alerts