Efficacy and Safety of the PRESERFLO™ MicroShunt in Pediatric Glaucoma.

Abstract

Prcis: PRESERFLO™ significantly reduced both intraocular pressure and the number of glaucoma medications in selected cases of pediatric glaucoma, as far as a 2-year period, with a favorable safety profile.

Purpose: To assess the efficacy and safety of the PRESERFLO™ device in selected cases of pediatric glaucoma.

Methods: Retrospective multi-center observational study. Patients ≤18 years of age who underwent PRESERFLO™ implantation with at least 6 months of follow-up were included. Primary outcome was surgical success, defined as an intraocular pressure between 6 - 21 mmHg with a reduction of ≥20% (criterion A) or ≥30% (criterion B), no need for further surgery and no severe surgery-related complications. Secondary outcomes included postoperative intraocular pressure, number of hypotensive drugs and adverse effects.

Results: Twenty eyes from 20 patients (mean age 11.7±1.1 y) were included, most with uveitic glaucoma (n=8 eyes; 40%). Average follow-up was 18.3±7.7 months, with 55% (n=11) completing 24 months. Mean intraocular pressure was significantly reduced from 27.8±1.3 mmHg at baseline to 14.2±8.5 mmHg and 14.6±13.9 mmHg at 12 and 24 months, respectively (P<0.001 for both). Average medication reduced from 2.9±1.1 to 0.9±1.3 (P=0.006) at 24 months. Qualified surgical success (regardless of medication) was 60% and 50% after 12 months, for criteria A and B, and 45% at 24 months (criteria A and B). In both time-points and for both criteria, 35% of cases were complete successes (drop-free). No sight-threatening complications were registered.

Conclusion: Real-world data from PRESERFLO™ use suggests this to be a safe and effective surgical option for the treatment of selected cases of pediatric glaucoma.