Journal francais d'ophtalmologie · 2026
Real-life outcomes of the PAUL® Glaucoma Implant with ripcord in refractory glaucoma.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Heintz V, Bastelica P, Baudouin C, Rousseau A, Labetoulle M, Bodaghi B, Debillon L, Vest A, Chami Y, Lecannuet A, Bouvet M, Lama H, Bistour A, Brézin A, Labbé A, Lachkar Y
Аннотация
PURPOSE: This study aimed to evaluate the one-year efficacy and safety of the PAUL® Glaucoma Implant with ripcord for treating refractory glaucoma.
METHODS: 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.
RESULTS: 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%).
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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%).
CONCLUSION: 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.