PAUL glaucoma implant - efficacy and safety: A systematic review and meta-analysis

BackgroundThis systematic review and meta-analysis aim to evaluate the efficacy and safety of the PAUL(R) Glaucoma Implant in reducing intraocular pressure and number of anti-glaucoma medication use in both adult and paediatric populations. MethodsA systematic review was conducted following the PRISMA guidelines. The databases PubMed, Ovid-Embase and Scopus were searched to include studies published between January 2017 and September 2025. Studies were stratified by age and risk of bias was assessed using the Newcastle-Ottawa Scale for observational studies and ROBUST-RCT for randomized trials. Primary outcomes were intraocular pressures and number of glaucoma medications at each follow-up visits. Random effects meta-analyses were performed. Secondary outcome was complications. ResultsTwenty-four studies (twenty adults, four paediatric) comprising 836 eyes were included in our review and meta-analysis. Both adult and paediatric patients showed significant IOP reduction post-surgery, with a mean difference of 17.48 mmHg (95% CI: 14.59, 20.37) and 20.31 mmHg (95% CI: 7.80, 32.82) at 1 week, respectively, and sustained reductions at 12 months. The reduction in glaucoma medications was 79.2% for adults and 71.4% for children at 12 months. Subgroup analyses demonstrated greater IOP reduction in studies conducted in the Middle East. The uses of Mitomycin C did not significantly affect outcomes. ConclusionThe PAUL(R) glaucoma implant showed significant and sustained IOP reductions with reduced need for glaucoma medications. The PAUL(R) glaucoma implant is a promising surgical option for glaucoma management in both adults and children. Further long-term prospective comparative studies are needed to assess long-term efficacies and allow direct comparisons with other glaucoma drainage devices.