Safety and Efficacy of Preserflo Microshunt in Different Subtypes of Glaucoma.

Abstract

Background: Glaucoma is the leading cause of blindness worldwide. Intraocular pressure is considered the only modifiable risk factor; different modalities have been developed to target this risk factor. Trabeculectomy, a gold standard glaucoma surgery, carries high complication rate, as a result alternative different modalities were developed to mitigate this risk. A newly developed device, Preserflo Microshunt, aims to decrease the complication rate of trabeculectomy with similar efficacy. In this study, we assessed the safety and efficacy of the device in Saudi Arabia, where the patient population has a darker skin color with more intense scarring and a hot climate that can exacerbate ocular surface dryness and compromise conjunctival health.

Purpose: This retrospective study aims to assess the safety and efficacy of Preserflo Microshunt with Mitomycin C 0.5 mg/mL in managing different subtypes of glaucoma.

Methods: Retrospective, interventional single-arm study.

Results: This study included 45 eyes from 45 patients. It included 33 (73.3%) males and 12 (26.7%) females. A median age of 56 years (Interquartile Range 39-63, range 20-77). The Preserflo Microshunt with Mitomycin C 0.5 mg/mL achieved a complete success rate 83.3% at 6 months follow-up and of 80% at 1 year. A significant reduction in both the number of anti-glaucoma medications and intraocular pressure at 1 month, 3 months, 6 months, and 1 year post-operatively was observed (P<0.001 for all). The most common early-onset complication was transient hypotony, observed in 12 eyes (26.7%), and the most common late-onset complication was cataract progression, which was observed in 5 (16.67%) patients at 1 year.

Conclusion: Preserflo Microshunt is a viable option for glaucoma patients showing excellent success and low complication rates with good safety profile.