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Early Complications and Results of Preserflo MicroShunt in the Management of Uncontrolled Open-Angle Glaucoma: A Case
Emil Saeed1, Renata Zalewska1, Joanna Konopińska1
1Department of Ophthalmology, Medical University of Bialystok, 15-276 Bialystok, Poland.
Abstract:
We analyze the surgical outcomes and early complications with their management of the Preserflo MicroShunt (Santen Pharmaceutical Co., Ltd., Osaka, Japan) at six-month follow-up. The study is conducted between March 2021 and May 2022. Best-corrected visual acuity (BCVA) logMAR, intraocular pressure (IOP), and changes in glaucoma medications are assessed. Thirty eyes of 30 patients (22 women [73.3%] and 8 men [26.7%]) are included. They are augmented with mitomycin C (MMC) 0.5 mg/mL (8 subjects) or MMC 0.2 mg/mL (22 subjects) intraoperatively. BCVA is significantly higher one day after the treatment than before the treatment (MD with 95% CI = 0.05 (<0.01; 0.30); p = 0.045) when analyzing all patients. Such dependency is not observed when analyzing only patients treated with MMC 0.2 or 0.5 mg/mL (p > 0.050 for both analyses). No other statistically significant differences are detected in the level of BCVA before and after treatment. Among the patients, overall IOP is significantly lower at each time point after treatment than before surgery (p < 0.001 for all analyses). Among patients augmented with MMC 0.2 mg/mL, the IOP level is also significantly lower at each time point after treatment than before treatment (p ≤ 0.001 for all analyses). The same differences are observed among patients with MMC = 0.5—the IOP level is significantly lower at each time point after treatment than before treatment (p < 0.050 for all analyses). Five subjects (16.7%) require anti-glaucoma medications three months after the procedure. Early complications (hypotony, choroidal effusion, keratitis, hyphema, and bleb fibrosis) are observed in 46.7% of cases. Our early results show that Preserflo MicroShunt is safe and effective for lowering IOP; however, it is not free from transient complications.
Insights
The Preserflo MicroShunt effectively lowers intraocular pressure (IOP) in glaucoma patients. While generally safe, early complications like hypotony and bleb fibrosis occurred in 46.7% of cases.
Area of Science:
- Ophthalmology
- Glaucoma Surgery
- Medical Devices
Background:
- Glaucoma management often requires surgical intervention to reduce intraocular pressure (IOP).
- The Preserflo MicroShunt is a device designed for glaucoma surgery to improve aqueous humor outflow.
Purpose of the Study:
- To evaluate the surgical outcomes and early complications of the Preserflo MicroShunt at six-month follow-up.
- To assess the impact of the Preserflo MicroShunt on best-corrected visual acuity (BCVA) and IOP.
- To analyze the need for glaucoma medications post-implantation.
Main Methods:
- A prospective study including 30 eyes of 30 patients undergoing Preserflo MicroShunt implantation.
- Intraoperative augmentation with mitomycin C (MMC) at concentrations of 0.2 mg/mL or 0.5 mg/mL.
- Assessment of BCVA, IOP, and medication use at various time points up to six months post-surgery.
Main Results:
- Overall IOP was significantly reduced at all post-treatment time points compared to pre-surgery levels (p < 0.001).
- A significant improvement in BCVA was noted one day after surgery for all patients (p = 0.045), but not consistently across subgroups.
- Early complications occurred in 46.7% of cases, including hypotony, choroidal effusion, keratitis, hyphema, and bleb fibrosis.
- 16.7% of patients required anti-glaucoma medications at three months post-procedure.
Conclusions:
- The Preserflo MicroShunt demonstrates safety and efficacy in lowering IOP for glaucoma patients.
- While effective, the device is associated with transient early complications that require monitoring and management.
- Further long-term studies are warranted to fully understand the risk-benefit profile of the Preserflo MicroShunt.
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