Randomised Clinical Trial for Postoperative Complications after Ex-PRESS Implantation versus Trabeculectomy with 2-Year Follow-Up

Abstract

We compared complications between Ex-PRESS implantation and trabeculectomy for 2 years after surgery. Sixty-four open-angle glaucoma eyes were randomly assigned to treatment with trabeculectomy (n = 32) or Ex-PRESS implantation (n = 32). The primary outcomes were postoperative complications, including reduction of the endothelial cell density (ECD) of the cornea, cataract progression and the frequency of other late postoperative complications. The Ex-PRESS group had significantly greater reduction of postoperative corneal ECD than the trabeculectomy group did at 2 years after surgery (P = 0.026). Among the corneal areas measured using specular microscopy, the superior area, where the Ex-PRESS tube was inserted, had significantly more severe corneal ECD reduction than the inferior area after 2 years (−17.6% in superior area and −11.7% in inferior area, P = 0.04). More cataract progression occurred in the trabeculectomy group than in the Ex-PRESS group (P = 0.04). Twelve eyes (37.5%) in the trabeculectomy group and 4 eyes (12.5%) in the Ex-PRESS group underwent cataract surgery (P = 0.019). The total number of other postoperative complications between 3 months and 2 years was significantly higher in the trabeculectomy group than in the Ex-PRESS group (P = 0.02). Although Ex-PRESS implantation might be associated with an increased rate of corneal endothelial cell loss compared with trabeculectomy, it is beneficial for preventing cataract progression after filtering surgery.

EX-PRESS Glaucoma Filtration Device: Management of Complications

“…The physiopathological mechanism underlying the damage to the corneal endothelial cells following EX-PRESS implantation remains unknown, with recent data suggesting that it might be different from that of corneal endothelial cell loss after trabeculectomy. The corneal superior area, where the EX-PRESS device was inserted, was found to have significantly more severe corneal endothelial cellular density reduction than the inferior area 2 years after surgery, whereas no area dependency was observed in patients who underwent trabeculectomy [40].…”

“…Recent studies evaluating longer follow-ups demonstrate a statistically significant reduction of the corneal endothelium cell density, which was found by Ishida et al 24 months after EX-PRESS implantation [38], compared to the normal corneal endothelium decrease rate of 0.6% per year [39]. While comparing postoperative complications between trabeculectomy and EX-PRESS implantation with 2 years of follow-up, Arimura et al showed that EX-PRESS is associated with a significantly greater reduction of corneal endothelial cell density than trabeculectomy, especially in the corneal area around the tube [40].…”

Comparison of Ex-PRESS P-200 mini-shunt implantation and standard trabeculectomy for open-angle glaucoma: four-year follow-up

“…The efficacy and safety of the Ex-PRESS shunt are already known, and the low complication rate compared to standard trabeculectomy as well as good IOP control has already been demonstrated. However, the follow-up of the previous reports is up to 3 years [24][25][26]40]. Moreover, all patients received anti-mitotic medication as adjuvant therapy for postoperative IOP control [24][25][26]40].…”

“…However, the follow-up of the previous reports is up to 3 years [24][25][26]40]. Moreover, all patients received anti-mitotic medication as adjuvant therapy for postoperative IOP control [24][25][26]40]. The added value of our study is represented by a longer follow-up of patients with Ex-PRESS intervention without anti-mitotic medication.…”

“…By contrast, in the case of neovascular glaucoma, standard trabeculectomy proved better performances as compared to Ex-PRESS. Ex-PRESS shunt interventions differ from one study to another, in terms of what and how frequently, but all patients received mitomycin C as anti-mitotic medication (Table I) [17][18][19][20][21][22][23][24][25][26][27].…”