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 multicenter observational study. Patients aged 18 years or younger who underwent Preserflo implantation with at least 6 months of follow-up were included. The primary outcome was a surgical success, defined as an intraocular pressure between 6 and 21 mm Hg 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 mm Hg at baseline to 14.2±8.5 mm Hg and 14.6±13.9 mm Hg 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.