Purpose: To compare the effectiveness and safety of the Paul Glaucoma Implant (PGI; Advanced Ophthalmic Innovations, Singapore, Republic of Singapore) and the Baerveldt Glaucoma Implant (BGI; Abbott Medical Optics, Santa Ana, CA, USA) in pediatric glaucoma over 24 months. Design: Retrospective, comparative cohort study. Participants: Thirty-three eyes from 30 pediatric patients (≤18 years) with primary or secondary glaucoma, treated with PGI (18 eyes) or BGI (15 eyes). Methods: All surgeries were performed by a single surgeon between April 2020 and October 2023. Follow-up data were analysed up to 24 months. Main outcome measures: The primary outcome was IOP reduction. Secondary outcomes included complete and qualified success, surgical failure, number of IOP-lowering medications, need for postoperative IOP-control procedures, best-corrected visual acuity (BCVA), and complications. Result: Baseline IOP was 29.5 ± 5.0 mmHg in PGI eyes and 30.3 ± 6.7 mmHg in BGI eyes. At 24 months, IOP decreased to 13.6 ± 3.5 mmHg and 12.4 ± 4.7 mmHg, respectively, representing significant reductions from baseline in both groups (p<0.05), with no between-group difference (p=0.42). Medication use decreased from 2.8 ± 0.9 to 1.2 ± 1.3 in the PGI group and from 3.1 ± 0.8 to 1.5 ± 1.2 in the BGI group, with significant intragroup reductions in both cohorts (p<0.05) and no significant difference between groups at 24 months (p=0.76). Qualified success at 24 months was comparable (72.2% vs 73.3%), with a non-significant trend towards higher complete success with PGI (38.9% vs 13.3%). BCVA remained stable in both groups. Complications occurred in 16.7% of PGI and 40.0% of BGI eyes, including a trend toward fewer hypotony-related shallow anterior chambers with PGI (0% vs 20%, p=0.09). Conclusions: Both implants achieved substantial and sustained IOP reduction, reduced medication burden, and comparable complete and qualified success. PGI demonstrated a favorable safety profile, with few hypotony-related events, suggesting potential advantages linked to its intrinsic flow-restricting design in pediatric eyes.

Paul vs Baerveldt Implants in Pediatric Glaucoma: A 24-Month Retrospective Study / Sacchi, M., Tomaselli, D., Monsellato, G., Morante, D., Sabella, P., Dore, S., Pinna, A., Nucci, P.. - In: OPHTHALMOLOGY GLAUCOMA. - ISSN 2589-4196. - (2026). [10.1016/j.ogla.2026.07.005]

Paul vs Baerveldt Implants in Pediatric Glaucoma: A 24-Month Retrospective Study

Sacchi, Matteo;Dore, Stefano;Pinna, Antonio;
2026-01-01

Abstract

Purpose: To compare the effectiveness and safety of the Paul Glaucoma Implant (PGI; Advanced Ophthalmic Innovations, Singapore, Republic of Singapore) and the Baerveldt Glaucoma Implant (BGI; Abbott Medical Optics, Santa Ana, CA, USA) in pediatric glaucoma over 24 months. Design: Retrospective, comparative cohort study. Participants: Thirty-three eyes from 30 pediatric patients (≤18 years) with primary or secondary glaucoma, treated with PGI (18 eyes) or BGI (15 eyes). Methods: All surgeries were performed by a single surgeon between April 2020 and October 2023. Follow-up data were analysed up to 24 months. Main outcome measures: The primary outcome was IOP reduction. Secondary outcomes included complete and qualified success, surgical failure, number of IOP-lowering medications, need for postoperative IOP-control procedures, best-corrected visual acuity (BCVA), and complications. Result: Baseline IOP was 29.5 ± 5.0 mmHg in PGI eyes and 30.3 ± 6.7 mmHg in BGI eyes. At 24 months, IOP decreased to 13.6 ± 3.5 mmHg and 12.4 ± 4.7 mmHg, respectively, representing significant reductions from baseline in both groups (p<0.05), with no between-group difference (p=0.42). Medication use decreased from 2.8 ± 0.9 to 1.2 ± 1.3 in the PGI group and from 3.1 ± 0.8 to 1.5 ± 1.2 in the BGI group, with significant intragroup reductions in both cohorts (p<0.05) and no significant difference between groups at 24 months (p=0.76). Qualified success at 24 months was comparable (72.2% vs 73.3%), with a non-significant trend towards higher complete success with PGI (38.9% vs 13.3%). BCVA remained stable in both groups. Complications occurred in 16.7% of PGI and 40.0% of BGI eyes, including a trend toward fewer hypotony-related shallow anterior chambers with PGI (0% vs 20%, p=0.09). Conclusions: Both implants achieved substantial and sustained IOP reduction, reduced medication burden, and comparable complete and qualified success. PGI demonstrated a favorable safety profile, with few hypotony-related events, suggesting potential advantages linked to its intrinsic flow-restricting design in pediatric eyes.
2026
Paul vs Baerveldt Implants in Pediatric Glaucoma: A 24-Month Retrospective Study / Sacchi, M., Tomaselli, D., Monsellato, G., Morante, D., Sabella, P., Dore, S., Pinna, A., Nucci, P.. - In: OPHTHALMOLOGY GLAUCOMA. - ISSN 2589-4196. - (2026). [10.1016/j.ogla.2026.07.005]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11388/389629
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