Two-Year Performance and Safety Results of the MINIject Supraciliary Implant in Patients With Primary Open-Angle Glaucoma: Meta-Analysis of the STAR-I, II, III Trials.
Dick H Burkhard, Mackert Marc J, Ahmed Iqbal Ike K, Denis Philippe, Hirneiß Christoph, Flowers Brian E, Singh I Paul, Mansouri Kaweh, Fea Antonio M
AI Summary
This meta-analysis found the MINIject supraciliary implant safely and effectively lowered IOP and medication burden in POAG patients for two years, offering a bleb-free treatment option.
Abstract
Purpose
To evaluate the performance and safety of minimally invasive glaucoma surgery with a supraciliary drainage device (MINIject; iSTAR Medical, Wavre, Belgium) in primary open-angle glaucoma (POAG) as a stand-alone procedure.
Design
Meta-analysis.
Methods
At 11 sites in Colombia, France, Germany, India, Panama, and Spain, 82 patients were treated in 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III). Data were pooled in a meta-analysis of up to 2 years of follow-up postimplantation. The main outcome measures were mean relative and absolute reduction in diurnal intraocular pressure (IOP) compared to baseline. Secondary outcomes included patients with IOP ≤18 mmHg, patients with IOP reduction ≥20%, number of IOP-lowering medications, adverse events, and endothelial cell density loss.
Results
At the 2-year follow-up (n = 66), mean IOP was reduced from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (-39.3%; P < 0.0001). An IOP reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg. IOP-lowering medications were reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001), with 37.9% of patients being medication-free at 2 years. Mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline and no patient had a loss >30%.
Conclusions
This meta-analysis demonstrates the favorable safety and efficacy profile of a supraciliary device implanted in a stand-alone, ab-interno procedure in patients with mild-to-moderate POAG. The data demonstrate that MINIject is a safe and effective, bleb-free treatment option for patients requiring low target IOP up to 2 years.
MeSH Terms
Shields Classification
Key Concepts5
In a meta-analysis of 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III) involving 82 patients, the MINIject supraciliary implant reduced mean intraocular pressure (IOP) from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (-39.3%; P < 0.0001) at the 2-year follow-up (n = 66) in patients with primary open-angle glaucoma.
In a meta-analysis of 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III) involving 82 patients, an intraocular pressure (IOP) reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg at the 2-year follow-up (n = 66) after implantation of the MINIject supraciliary implant in patients with primary open-angle glaucoma.
In a meta-analysis of 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III) involving 82 patients, the number of IOP-lowering medications was reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001) at the 2-year follow-up (n = 66) after implantation of the MINIject supraciliary implant in patients with primary open-angle glaucoma.
In a meta-analysis of 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III) involving 82 patients, 37.9% of patients were medication-free at 2 years after implantation of the MINIject supraciliary implant in patients with primary open-angle glaucoma.
In a meta-analysis of 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III) involving 82 patients, the mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline, and no patient had a loss >30% after implantation of the MINIject supraciliary implant in patients with primary open-angle glaucoma.
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