EARLY CLINICAL OUTCOMES OF THE PRESERFLO MICROSHUNT DEVICE

Published 2022 - 26th ESCRS Winter Meeting

Reference: MP10 | Type: Abstracts | DOI: 10.82333/e4ym-cb21

Authors: Rafael Correia Barão ¹ , André Barata ¹ , Patrícia José ¹ , Diogo Matos* ¹ , Pedro Gomes ¹ , Riccardo Peschiera ¹ , Luís Abegão Pinto ¹

¹Ophthalmology,Hospital de Santa Maria, CHULN,Lisboa,Portugal

Purpose

The Preserflo Microshunt is an ab externo sub-Tenon’s aqueous shunt approved for treatment of medically uncontrolled glaucoma. The purpose of this study was to assess the efficacy and safety profile of this device.

Setting

Glaucoma Department at a tertiary hospital.

Methods

Retrospective single-center observational study. Patients who underwent standalone or combined phacoemulsification-Preserflo Microshunt implantation with a minimum of 3 months of post-operative follow-up were included. Primary outcome measures included surgical success defined as a ≥ 30% decrease in IOP from baseline and unmedicated IOP ≤ 18 mmHg. Secondary outcomes included number of hypotensive drops and adverse effects.

Results

Our sample included 92 eyes from 77 patients (mean±SD age 68±18 years), most of which underwent standalone surgery (n=74 eyes; 80%). Average post-operative follow-up time was 9±6 months (range 3-25), with over three quarters of eyes (n=70; 76%) completing at least 6 months of follow-up and a third (n=30; 33%) with at least 12 months. Mean IOP was significantly from baseline throughout follow-up (baseline: 22±5.8 mmHg vs. 11.1±4.3 month 1, 11.5±4.5 month 3, 12.8±5.1 month 6 and 14±4.7 mmHg at 12 months (p<0.0001, all comparisons). Mean IOP reduction was not different comparing standalone and combined surgery at last follow-up (12.6±5.2 vs. 12.2±3.5 mmHg, respectively; p=0.996). Mean number of medications was reduced from 2.8±0.9 to 0.5±0.9 at last follow-up (p<0.0001), with 75% of eyes remaining drop-free throughout follow-up. Absolute success at 12 months 46%, increasing to 64% if medication was allowed (qualified success). Complications included intra-operative bleeding or post-operative hyphema (total n=9; 10%), and shallow anterior chamber (n=4; 4%), which resolved spontaneously in all patients. No major or sight-threatening complication was recorded.

Conclusion

Early audit of real-world data from Preserflo use suggests this to be a safe and effective surgical option for the treatment of medically uncontrolled glaucoma. Long term follow-up is needed to properly place this device in the glaucoma surgical arsenal.