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

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.