The PAUL® glaucoma implant: 1-year results of a novel glaucoma drainage device in a paediatric cohort.

Abstract

The PAUL® glaucoma implant (PGI) is a novel glaucoma drainage device, which has not been previously reported in paediatric glaucoma management. This study aims to evaluate the safety and effectiveness of the PGI in a paediatric cohort. A retrospective evaluation of 25 cases of paediatric PGI surgery (age 8months to 16years) wasperformed at Manchester Royal Eye Hospital between September 2019 and July 2020. Primary outcome measures included failure (intraocular pressure (IOP) > 21mmHg or < 20% reduction of IOP, removal of the implant, further glaucoma intervention or visual loss. Secondary outcomes included mean IOP, mean number of medications, logMAR visual acuity and complications. Eleven eyes (48%) had a complete success and achieved an unmedicated IOP < 21mmHg, and 21 eyes (84%) had a qualified success (with or without medications). Four failures were observed, 2 due to hypotony and 2 underwent further surgery (gonioscopy-assisted transluminal trabeculotomy). The mean preop IOP was 30.9 ± 5.9mmHg (n = 25), falling to 13.5 ± 6.8mmHg at 1month, 17.9 ± 7.2mmHg at 3months, 13.4 ± 5.1mmHg at 6months, 13.2 ± 4.9mmHg at 12months and 11.8 ± 4.6mmHg at 24months. The mean change in IOP from the preoperative visit to the last visit was a reduction of 19.1 ± 7.7mmHg. A significant reduction in the number of medications and IOP was demonstrated after PGI (p < 0.0001). Nine patients required removal of the intraluminal Prolene stent from the PGI for further pressure lowering. The one- to two-year results demonstrate paediatric PGI has high qualified success rates and effectively reduces IOP and the need for glaucoma medical therapy.