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

Abstract

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.