Advanced Ophthalmic Innovations' Paul glaucoma implant (PGI) delivers sustained pressure-lowering with a favourable safety profile in refractory glaucoma, according to the first systematic review and meta-analysis of its clinical performance.
Writing in Clinical & Experimental Ophthalmology, researchers in Singapore said the findings provide pooled evidence supporting the device’s role in challenging cases.
The review identified 15 studies reporting 640 eyes implanted with the valveless PGI. Researchers analysed IOP control, medication use, success rates and complications. At 12 months, mean IOP was reduced by 16.11mmHg from baseline and patients required more than two fewer IOP-lowering medications. ‘Complete success’ at 12 months averaged 50.22%, while ‘qualified success’ was 92.40%, said researchers.
Post-operative complications were generally uncommon, with hypotony and hyphaema occurring in around 6% and 5% of eyes, respectively, while sight-threatening events, such as corneal decompensation and endophthalmitis, were rare. Mean visual acuity remained stable, compared with baseline, the authors said.
The data indicate the Paul implant is effective and safe for refractory glaucoma, they concluded, noting one senior author holds a patent related to the PGI.
