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Efficacy and Safety of the Preserflo MicroShunt in Pediatric Glaucoma
Susana Rebocho Duarte1,2, Afonso Lima-Cabrita1,2, Rafael Correia Barão1,2
1Department of Ophthalmology, Unidade Local de Saúde de Santa Maria.
Insights
Preserflo implantation effectively lowered intraocular pressure and reduced glaucoma medication needs in pediatric patients over two years. The study found a favorable safety profile for this glaucoma treatment option.
Area of Science:
- Ophthalmology
- Surgical Innovation
- Pediatric Glaucoma Management
Background:
- Pediatric glaucoma presents unique management challenges.
- The Preserflo device offers a novel surgical approach for intraocular pressure (IOP) control.
- Evaluating its efficacy and safety in young patients is crucial.
Purpose of the Study:
- To assess the efficacy and safety of the Preserflo device in selected pediatric glaucoma cases.
- To determine the impact on intraocular pressure and medication requirements.
- To evaluate the long-term outcomes over a 2-year period.
Main Methods:
- Retrospective multicenter observational study.
- Inclusion of pediatric patients (≤18 years) with Preserflo implantation and ≥6 months follow-up.
- Primary outcome: Surgical success defined by IOP range (6-21 mmHg) with ≥20% or ≥30% reduction, no further surgery, and no severe complications. Secondary outcomes included IOP, medication use, and adverse events.
Main Results:
- Mean IOP significantly reduced from 27.8 mmHg at baseline to 14.2 mmHg at 12 months and 14.6 mmHg at 24 months (P <0.001).
- Average glaucoma medication reduced from 2.9 to 0.9 at 24 months (P =0.006).
- Qualified surgical success rates were 60% (criterion A) and 50% (criterion B) at 12 months, and 45% at 24 months. No sight-threatening complications were observed.
Conclusions:
- Preserflo implantation demonstrated significant IOP reduction and decreased medication needs in pediatric glaucoma patients.
- The device exhibited a favorable safety profile with no sight-threatening complications over a 2-year follow-up.
- Real-world data suggests Preserflo is a safe and effective surgical option for selected pediatric glaucoma cases.
PréCis:
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.
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