Clinical outcomes of the PAUL® glaucoma implant: One-year results.


Journal

Clinical & experimental ophthalmology
ISSN: 1442-9071
Titre abrégé: Clin Exp Ophthalmol
Pays: Australia
ID NLM: 100896531

Informations de publication

Date de publication:
08 2023
Historique:
revised: 28 03 2023
received: 16 12 2022
accepted: 22 04 2023
medline: 23 10 2023
pubmed: 10 5 2023
entrez: 9 5 2023
Statut: ppublish

Résumé

To report one-year outcomes from a single-centre cohort undergoing PAUL® Glaucoma Implant (PGI) surgery. Retrospective review of patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from April 2021 to September 2021. Forty-five eyes of 41 patients were included. Qualified and complete success rates (95% CI) were 95.6% (88.9%-100%) and 73.3% (60%-86.7%) for Criterion A (IOP ≤ 21 mmHg), 84.4% (73.3%-93.3%) and 74.4% (51.1%-80.0%) for Criterion B (IOP ≤ 18 mmHg), 62.2% (48.9%-75.6%) and 46.7% (31.2%-62.2%) for Criterion C (IOP ≤ 15 mmHg) and 26.7% (13.3%-40.0%) and 22.2% (11.1%-33.3%) for Criterion D (IOP ≤ 12 mmHg), respectively. Mean IOP decreased from 26.1 mmHg (7-48 mmHg) to 12.0 mmHg (3-24 mmHg) (reduction of 48.83%) after 12 months with a reduction of IOP-lowering agents from 0.5 (0-3). One eye (2.2%) needed an injection of viscoelastic due to significant hypotony with AC shallowing, and four eyes (8.9%) developed choroidal detachments due to hypotony which resolved without further interventions after 6 weeks. Three patients (6.7%) developed tube exposure which required conjunctival revision with an additional pericardial patch graft. An intraluminal prolene stent was removed in 19 eyes (42.2%) after a mean time period of 8.4 months (2-12 m). Mean IOP before the removal was 21.9 mmHg (12-38 mmHg) and decreased to 11.3 mmHg (6-16 mmHg). PGI surgery is an effective procedure for reducing IOP and pressure-lowering therapy. An intraluminal prolene stent impedes hypotony in the early postoperative phase and enables further IOP lowering without additional interventions during the postoperative course.

Sections du résumé

BACKGROUND
To report one-year outcomes from a single-centre cohort undergoing PAUL® Glaucoma Implant (PGI) surgery.
METHODS
Retrospective review of patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from April 2021 to September 2021.
RESULTS
Forty-five eyes of 41 patients were included. Qualified and complete success rates (95% CI) were 95.6% (88.9%-100%) and 73.3% (60%-86.7%) for Criterion A (IOP ≤ 21 mmHg), 84.4% (73.3%-93.3%) and 74.4% (51.1%-80.0%) for Criterion B (IOP ≤ 18 mmHg), 62.2% (48.9%-75.6%) and 46.7% (31.2%-62.2%) for Criterion C (IOP ≤ 15 mmHg) and 26.7% (13.3%-40.0%) and 22.2% (11.1%-33.3%) for Criterion D (IOP ≤ 12 mmHg), respectively. Mean IOP decreased from 26.1 mmHg (7-48 mmHg) to 12.0 mmHg (3-24 mmHg) (reduction of 48.83%) after 12 months with a reduction of IOP-lowering agents from 0.5 (0-3). One eye (2.2%) needed an injection of viscoelastic due to significant hypotony with AC shallowing, and four eyes (8.9%) developed choroidal detachments due to hypotony which resolved without further interventions after 6 weeks. Three patients (6.7%) developed tube exposure which required conjunctival revision with an additional pericardial patch graft. An intraluminal prolene stent was removed in 19 eyes (42.2%) after a mean time period of 8.4 months (2-12 m). Mean IOP before the removal was 21.9 mmHg (12-38 mmHg) and decreased to 11.3 mmHg (6-16 mmHg).
CONCLUSIONS
PGI surgery is an effective procedure for reducing IOP and pressure-lowering therapy. An intraluminal prolene stent impedes hypotony in the early postoperative phase and enables further IOP lowering without additional interventions during the postoperative course.

Identifiants

pubmed: 37160354
doi: 10.1111/ceo.14235
doi:

Substances chimiques

Polypropylenes 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

566-576

Informations de copyright

© 2023 The Authors. Clinical & Experimental Ophthalmology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Ophthalmologists.

Références

Aref AA, Gedde SJ, Budenz DL. Glaucoma drainage implant surgery. Dev Ophthalmol. 2017;59:43-52.
Pereira ICF, van de Wijdeven R, Wyss HM, Beckers HJM, den Toonder JMJ. Conventional glaucoma implants and the new MIGS devices: a comprehensive review of current options and future directions. Eye (Lond). 2021;35(12):3202-3221.
Lee RMH, Bouremel Y, Eames I, Brocchini S, Khaw PT. Translating minimally invasive glaucoma surgery devices. Clin Transl Sci. 2020;13(1):14-25.
Molteno AC. New implant for drainage in glaucoma. Br J Ophthalmol. 1969;53(3):161-168.
Ayyala RS, Duarte JL, Sahiner N. Glaucoma drainage devices: state of the art. Expert Rev Med Devices. 2006;3(4):509-521.
Schmidt W, Kastner C, Sternberg K, et al. New concepts for glaucoma implants-controlled aqueous humor drainage, encapsulation prevention and local drug delivery. Curr Pharm Biotechnol. 2013;14(1):98-111.
Lim KS. Control and optimisation of fluid flow in glaucoma drainage device surgery. Eye (Lond). 2018;32(2):230-234.
Kara E, Kutlar AI. CFD analysis of the Ahmed glaucoma valve and design of an alternative device. Comput Methods Biomech Biomed Engin. 2010;13(6):655-662.
Christakis PG, Kalenak JW, Tsai JC, et al. The Ahmed versus Baerveldt study: five-year treatment outcomes. Ophthalmology. 2016;123(10):2093-2102.
Rockwood EJ. The Ahmed Baerveldt comparison (ABC) study: long-term results, successes, failures, and complications. Am J Ophthalmol. 2016;163:xii-xiv.
Sharkawi E, Artes PH, Oleszczuk JD, et al. Systematic occlusion of shunts: control of early postoperative IOP and Hypotony-related complications following glaucoma shunt surgery. J Glaucoma. 2016;25(1):54-61.
Koh V, Chew P, Triolo G, Lim KS, Barton K. Treatment outcomes using the PAUL glaucoma implant to control intraocular pressure in eyes with refractory glaucoma. Ophthalmol Glaucoma. 2020;3(5):350-359.
Budenz DL, Barton K, Gedde SJ, et al. Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2015;122(2):308-316.
José P, Barão RC, Teixeira FJ, et al. One-year efficacy and safety of the PAUL glaucoma implant using a standardized surgical protocol. J Glaucoma. 2021;31:201-205.
Vallabh NA, Mason F, Yu JTS, et al. Surgical technique, perioperative management and early outcome data of the PAUL® glaucoma drainage device. Eye. 2021;36:1905-1910.
Tan MCJ, Chloe Choy HY, Koh Teck Chang V, et al. Two year outcomes of the Paul glaucoma implant for treatment of glaucoma. J Glaucoma. 2022;31:449-455.
Abd Elfattah D, Wagdy F, Mokbel T, Elsorogy H, Elhesy AA. Intraluminal stenting versus external ligation of Ahmed glaucoma valve in prevention of postoperative hypotony. Int J Ophthalmol. 2021;14(10):1560-1564.
Tao LW, Atik A, Kwon HJ, et al. Comparison between surgical outcomes of glaucoma drainage implant surgery performed with and without intraluminal stent. Clin Exp Ophthalmol. 2020;48(4):525-528.
Hitchings RA, Joseph NH, Sherwood MB, Lattimer J, Miller M. Use of one-piece valved tube and variable surface area explant for glaucoma drainage surgery. Ophthalmology. 1987;94(9):1079-1084.

Auteurs

Constance Weber (C)

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Sarah Hundertmark (S)

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Raffael Liegl (R)

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Anna S Jauch (AS)

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Isabel Stasik (I)

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Frank G Holz (FG)

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Karl Mercieca (K)

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH