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Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year
Henny J M Beckers1, Florent Aptel2, Carroll A B Webers1
1University Eye Clinic, Maastricht University Medical Center, Maastricht, the Netherlands.
Purpose:
To assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG).
Design:
The MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study.
Participants:
Eligible patients were aged 18-85 years with POAG inadequately controlled on maximal tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤35 mmHg or when glaucoma progression warranted surgery.
Methods:
The MicroShunt was implanted as a stand-alone procedure with adjunctive use of topical mitomycin C (MMC; 0.2-0.4 mg/ml) for 2-3 minutes.
Main Outcome Measures:
The primary effectiveness outcome was IOP reduction and success (not requiring reoperation or pressure failures [IOP > 21 mmHg and < 20% reduction in IOP]) at year 1. Additional end points at year 2 included IOP reduction, success, glaucoma medications, adverse events (AEs), and reoperations. Results are reported in the overall population and subgroups of patients receiving 0.2 or 0.4 mg/ml MMC.
Results:
In 81 patients, mean (± standard deviation [SD]) IOP decreased from 21.7 ± 3.4 mmHg at baseline to 14.5 ± 4.6 mmHg at year 1 and 14.1 ± 3.2 mmHg at year 2 (P < 0.0001). Overall success (with and without supplemental glaucoma medication use) at year 1 was 74.1%. Mean (± SD) number of medications decreased from 2.1 ± 1.3 at baseline to 0.5 ± 0.9 at year 2 (P < 0.0001), and 73.8% of patients were medication free. Most common nonserious AEs were increased IOP requiring medication or selective laser trabeculoplasty (25.9%) and mild-to-moderate keratitis (11.1%). There were 6 (7.4%) reoperations and 5 (6.2%) needlings by year 2. In an analysis (post hoc) according to MMC concentration, overall success was 78.1% (0.2 mg/ml) and 74.4% (0.4 mg/ml; P = 0.710). In the 0.2 and 0.4 mg/ml MMC groups, 51.9% and 90.3% of patients were medication free, respectively (P = 0.001). There was a trend toward lower IOP and higher medication reduction in the 0.4 mg/ml MMC subgroup.
Conclusions:
In this study, mean IOP and glaucoma medication reductions were significant and sustained over 2 years postsurgery. No long-term, sight-threatening AEs were reported. Further studies may confirm potential risk/benefits of higher MMC concentration.
Insights
The PRESERFLO® MicroShunt significantly reduced intraocular pressure and glaucoma medication needs for two years in primary open-angle glaucoma patients. No serious sight-threatening adverse events were reported, indicating a favorable safety profile.
Area of Science:
- Ophthalmology
- Glaucoma Surgery
- Medical Devices
Background:
- Primary open-angle glaucoma (POAG) is a leading cause of irreversible blindness.
- Effective management of POAG often requires surgical intervention to lower intraocular pressure (IOP).
- The PRESERFLO® MicroShunt offers a novel approach to glaucoma filtration surgery.
Purpose of the Study:
- To evaluate the safety and effectiveness of the PRESERFLO® MicroShunt in patients with POAG.
- To assess IOP reduction and surgical success rates over a two-year period.
- To monitor adverse events and the need for reoperation.
Main Methods:
- A 2-year, multicenter, single-arm study involving 81 patients with POAG.
- Implantation of the PRESERFLO® MicroShunt as a standalone procedure with topical mitomycin C (MMC).
- Primary endpoints included IOP reduction and success rates at year 1, with further assessments at year 2.
Main Results:
- Mean IOP decreased from 21.7 mmHg to 14.1 mmHg by year 2 (P < 0.0001).
- Overall success rate was 74.1% at year 1, with a significant reduction in glaucoma medications.
- 73.8% of patients were medication-free by year 2; common non-serious adverse events included IOP increase and keratitis.
Conclusions:
- The PRESERFLO® MicroShunt demonstrated significant and sustained IOP and medication reduction over two years.
- The procedure showed a favorable safety profile with no long-term, sight-threatening adverse events.
- Further research is suggested to explore the potential benefits of higher MMC concentrations.
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