Real-life outcomes of the PAUL® Glaucoma Implant with ripcord in refractory glaucoma

This study aimed to evaluate the one-year efficacy and safety of the PAUL® Glaucoma Implant with ripcord for treating refractory glaucoma.

Conducted between November 2021 and September 2023 across five hospitals in Île-de-France, France, the study included patients with refractory glaucoma who underwent stand-alone implantation of the PAUL® Glaucoma Implant with a ripcord technique. Two success criteria were assessed at 12 months: (1) complete success: intraocular pressure (IOP)≤21mmHg with a≥20% reduction in IOP without IOP-lowering medications, no additional filtering surgery, no chronic hypotony, defined as an IOP≤5mmHg measured at two successive visits 3 months apart, and no loss of light perception; (2) qualified success: same criteria as complete success but with the same or fewer IOP-lowering medications.

The study evaluated 41 eyes of 41 patients, all of whom had undergone at least one previous glaucoma surgery (mean 1.7 surgeries per patient) and a mean visual field deviation of -15.7dB. At 12 months, 39.0% of patients achieved complete success; 97.6% achieved qualified success. No additional filtering surgeries were required. The mean IOP decreased significantly from 28.7mmHg to 12.6mmHg (-53.0%, P<0.0001), and the mean number of IOP-lowering medications decreased from 3.9 to 1.2 (-69.4%, P<0.0001). Complications included transient hypotony in one patient (2.4%), spontaneously resolving choroidal detachment in seven patients (17.1%), tube exposure in one patient (2.4%), and diffuse corneal edema in two patients (4.9%).

The PAUL® Glaucoma Implant with ripcord appears safe and effective, reducing the risk of early postoperative hypotony and allowing further minimally invasive IOP-lowering during follow-up.