AN ESTABLISHED PATHWAY WITH A DEMONSTRATED RISK/BENEFIT RATIO
XEN® Gel Stent has a favorable risk/benefit ratio, with low rates of intraoperative complications and postoperative vision-threatening adverse events
The most common postoperative adverse events included best-corrected visual acuity loss of ≥ 2 lines (≤ 30 days 15.4%; > 30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any time (24.6%), IOP increase ≥ 10 mm Hg from baseline (21.5%), and needling procedure (32.3%).
Postoperative complications of clinical interest
- 1.5% bleb leak (without operative room or slit lamp revision)
- 0% bleb leak (with operative room or slit lamp revision)
- 3.1% choroidal effusion (extending posterior to equator, without blood)
- 0% choroidal effusion (all others)
- 0% chronic pain (present > 3 months)
- 1.5% corneal edema grade 3 or grade 4 (> 30 days postoperatively)
- 0% endophthalmitis
*No clinically significant consequences were associated with hypotony, such as choroidal effusions, suprachoroidal hemorrhage, or hypotony maculopathy. IOP < 6 mm Hg was defined as an adverse event, regardless of whether there were any associated complications or sequelae related to the low pressure. Thirteen cases occurred at the 1-day visit; there were no cases of persistent hypotony, and no surgical intervention was required for any case of hypotony.