Efficacy and Safety of the Preserflo MicroShunt in Pediatric Glaucoma.

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.