Outcomes and Risk Factors for Failure After PRESERFLO™ MicroShunt Implantation in a Multicenter Japanese Cohort

Area of Science:

• Ophthalmology
• Glaucoma Surgery
• Medical Device Evaluation

Background:

• Glaucoma management often requires sustained intraocular pressure (IOP) reduction.
• The PRESERFLO™ MicroShunt (PMS) is a device used to lower IOP.
• Real-world effectiveness data are crucial for understanding surgical device performance.

Purpose of the Study:

• To assess the real-world effectiveness of PRESERFLO™ MicroShunt (PMS) implantation.
• To identify risk factors associated with surgical failure after PMS implantation.
• To analyze outcomes in a large, multicenter Japanese patient cohort.

Main Methods:

• A retrospective cohort study involving 856 eyes from 699 patients who underwent PMS implantation.
• Surgical success was defined by IOP reduction (≥20% from baseline) meeting specific mmHg thresholds (≤18, ≤15, ≤12).
• Kaplan-Meier and Cox regression analyses were used to determine success rates and identify risk factors.

Main Results:

• Median IOP decreased from 18 mmHg to 11 mmHg at 12 months post-surgery (P < 0.001).
• Median medication use decreased from 4 to 0.
• Twelve-month complete success rates ranged from 59.4% to 69.5%, and qualified success rates ranged from 66.0% to 81.0% across different criteria.

Conclusions:

• PRESERFLO™ MicroShunt (PMS) implantation demonstrates sustained IOP reduction and reduced medication requirements in a large Japanese cohort.
• Factors such as prior cataract surgery and higher medication use were associated with treatment failure.
• Older age and posterior tube fixation were found to be protective factors, highlighting the importance of surgical technique and patient selection.