Efficacy and Safety of PreserFlo MicroShunt Implantation and Its Effects on Intraocular Inflammation through Laser Flare Photometry.

PURPOSE

The primary objective of this study is to evaluate the efficacy and safety profile of PreserFlo MicroShunt implantation in the medium- to long-term follow-up of patients with open-angle glaucoma. The secondary objective is to analyze laser flare meter (LFM) values before and after PreserFlo MicroShunt implantation.

METHODS

This prospective, observational, longitudinal single-center study included a total of 62 eyes from 54 patients. A subgroup of 27 eyes (26 patients) reached the 12-month follow-up. Success was defined based on three criteria: criterion A: IOP ≤21 mmHg and ≥20% reduction; criterion B: IOP ≤15 mmHg and ≥25% reduction; and criterion C: IOP ≤12 mmHg and ≥30% reduction. Success was further categorized as complete if achieved without IOP-lowering medications and qualified if achieved with medication administration. Other aspects evaluated included the number of IOP-lowering medications (baseline and postoperative), development of postoperative complications, 5-FU injections or implant revision, and LFM values.

RESULTS

The 12-month follow-up group (27 patients) was composed by 50% males and had a mean age of 75.54 ± 9.98 years. Success rates at 12 months were as follows: 78% for criterion A, 56% for criterion B, and 26% for criterion C. Complete success, as defined by criterion A, was achieved by 67% of the patients, 29% achieved qualified success, and one eye (4%) experienced failure. IOP decreased from 25.26 ± 1.67 mmHg at baseline to 14.81 ± 0.74 mmHg at 12 months. The number of medications decreased from 3.67 ± 1.30 at baseline to 0.48 ± 0.75 at 12 months. Reported complications were choroidal detachment (11%), hyphema (5%), and athalamia (flat anterior chamber) (2%) 13 eyes (48%) received 5-FU injections, while 7 eyes (26%) underwent implant revision. No significant increase in LFM values was observed. Eyes with a regular postoperative course and IOP ≤15 mmHg showed significantly lower LFM values than patients with unfavorable outcomes (IOP >15 mmHg, development of complications, 5-FU injection, or implant revision).

CONCLUSIONS

PreserFlo MicroShunt showed a significant reduction in IOP and a decrease in the number of IOP-lowering medications. Complications occurred at a modest frequency. The implant provides a minimally invasive approach with no significant increases in LFM values postoperatively. Higher LFM values correlate with unfavorable postoperative outcomes.