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. 2022 Oct;36(10):1905-1910.
doi: 10.1038/s41433-021-01737-1. Epub 2021 Sep 20.

Surgical technique, perioperative management and early outcome data of the PAUL® glaucoma drainage device

Neeru Amrita Vallabh  1   2 , Fiona Mason  2 , Jonathan T S Yu  2 , Kenneth Yau  2 , Cecilia H Fenerty  2   3 , Karl Mercieca  3   4 , Anne Fiona Spencer  2 , Leon Au  5
Affiliations

Surgical technique, perioperative management and early outcome data of the PAUL® glaucoma drainage device

Neeru Amrita Vallabh et al. Eye (Lond). 2022 Oct.

Abstract

Objectives: To describe a surgical technique and early post-operative outcomes for a novel glaucoma drainage device-the PAUL® glaucoma implant (PGI).

Methods: A consecutive cohort study of subjects who had PGI surgery between February 2019 and May 2020 with a minimum of 6-month follow-up. Primary outcome measures included failure (intraocular pressure (IOP) > 21 mmHg or a <20% reduction of IOP, removal of the implant, further glaucoma intervention or visual loss to no light perception). Secondary outcomes included mean IOP, mean number of medications, logMAR visual acuity (VA) and complications.

Results: Ninety-nine eyes of 97 patients had a preoperative IOP (mean ± standard deviation) of 28.1 ± 9.0 mmHg, falling to 18.2 ± 6.8 mmHg at 1 month, 17.9 ± 6.7 mmHg at 3 months and 13.6 ± 4.7 mmHg at 6 months. 52 patients had a 12-month mean IOP of 13.3 ± 4.4 mmHg. The mean change in number of medications was a reduction of 2.38 ± 1.48. A significant reduction in the number of medications and intraocular pressure was demonstrated after PGI (p < 0.0001). No significant change was demonstrated in VA (p = 0.1158). A total of nine cases were deemed failures (six had <20% IOP reduction from baseline and three had IOP >21 mmHg). Thirty-eight (38.4%) of eyes had complete success and achieved an unmedicated IOP <21 mmHg. Ninety (90.1%) of eyes were qualified successes (with or without topical medications). Seventy-four (74.7%) eyes have achieved an intraocular pressure of <15 mmHg. Two cases of hypotony were observed.

Conclusion: This study presents a safe surgical technique, which significantly reduces IOP and number of medications with minimal complications.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1. A figure to demonstrate the surgical technique for the insertion of the PAUL® glaucoma implant with Tutoplast®.
A PAUL® glaucoma implant, B insertion of prolene into the drainage device, C insertion of the tube and fixation with ethilon sutures, D placement of Tutoplast® over the tube and fixation with TISSEEL glue.
Fig. 2
Fig. 2. A Kaplan–Meier survival curve for eyes implanted with PAUL® glaucoma implant over the duration of their follow up.
Failure is defined as an intraocular pressure >21 mmHg or <20% reduction from baseline (with or without medications) on two consecutive visits after 3 months.
Fig. 3
Fig. 3. Mean intraocular pressure over time.
A graph to show the mean intraocular pressure (with 95% confidence interval error bars) prior to and after the insertion of the Paul glaucoma drainage device.
See this image and copyright information in PMC

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