Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes

J Glaucoma. 2020 Jul;29(7):536-541. doi: 10.1097/IJG.0000000000001520.

Abstract

Background/aims: Both eyes of a same person are not completely independent entities. The purpose of this study was to assess the difference in outcome between the first-operated eye and the fellow-operated eye following bilateral XEN surgery, and to identify potential success predictors for the fellow eye.

Methods: This single-site, prospective, nonrandomized interventional study investigated bilateral nonsimultaneous XEN gel stent implantation over 24 months. Its main outcome measure was surgical success, defined as unmedicated intraocular pressure (IOP) ≤15 mm Hg associated with a relative reduction ≥20%.

Results: Of 149 enrolled eyes, 74 eyes of 37 patients who underwent bilateral (standalone or combined) XEN implantation, within a mean of 50.5±74.3 days of each other, were analyzed. Postoperatively, mean medicated IOP decreased from 19.0±6.6 (first-operated) and 18.2±5.2 mm Hg (fellow) at baseline (P=0.209) to 13.7±4.0 (-27.9%; P<0.001; first-operated) and 14.1±3.6 mm Hg (-22.5%; P<0.001; fellow) after 2 years (P=0.673). Rates of complete success were comparable between first-operated and fellow eyes (P=0.65). At 2 years, among patients whose first-operated eyes were considered a failure, 92.0% of fellow eyes failed (P=0.001). The odd ratio of a fellow eye experiencing complete success were 16.1 (95% confidence interval: 2.5-101.9, P=0.003) if the first operated eye experienced complete success.

Conclusions: The present study demonstrated a strong association between first-operated eyes and fellow eyes following XEN gel stent implantation, in terms of surgical outcomes and IOP reduction. In effect, surgical success in the first-operated eye increases the odds of success in the fellow eye by 16-folds.

Trial registration: ClinicalTrials.gov NCT03151577.

Publication types

  • Clinical Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Female
  • Glaucoma Drainage Implants*
  • Glaucoma, Open-Angle / physiopathology
  • Glaucoma, Open-Angle / surgery*
  • Humans
  • Intraocular Pressure / physiology*
  • Male
  • Odds Ratio
  • Outcome Assessment, Health Care
  • Postoperative Period
  • Prospective Studies
  • Prosthesis Implantation
  • Tonometry, Ocular
  • Visual Acuity / physiology

Associated data

  • ClinicalTrials.gov/NCT03151577