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

Abstract

Purpose: 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. Methods: A retrospective evaluation of 25 cases of paediatric PGI surgery (age 8 months to 16 years) was performed at Manchester Royal Eye Hospital between September 2019 and July 2020. Primary outcome measures included failure (intraocular pressure (IOP) > 21 mmHg 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. Results: Eleven eyes (48%) had a complete success and achieved an unmedicated IOP < 21 mmHg, 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 ± 5.9 mmHg (n = 25), falling to 13.5 ± 6.8 mmHg at 1 month, 17.9 ± 7.2 mmHg at 3 months, 13.4 ± 5.1 mmHg at 6 months, 13.2 ± 4.9 mmHg at 12 months and 11.8 ± 4.6 mmHg at 24 months. The mean change in IOP from the preoperative visit to the last visit was a reduction of 19.1 ± 7.7 mmHg. 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. Conclusion: 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. [Figure not available: see fulltext.].