Safety And Effectiveness Evaluation Of The Preserflo® Microshunt Glaucoma Device With Mitomycin C (Mmc) In Patients With Primary Open Angle Glaucoma
Published 2024 - 42nd Congress of the ESCRS
Reference: PO1057 | Type: Free paper | DOI: 10.82333/bn6h-pg46
Authors: Shamira Perera* 1 , Yamon Thant Syn 1 , Ching Lin Ho 1 , Tina Wong 1 , Zhu Li Yap 1 , Hla Myint Htoon 2
1Glaucoma,SNEC,Singapore,Singapore, 2Glaucoma,SERI,Singapore,Singapore
Purpose
The PRESERFLO® MicroShunt Glaucoma Device is an implantable device that shows promise in reducing intraocular pressure (IOP) in Caucasian eyes. However, its effectiveness and safety in Asian populations, known for scarring, have not been established. To address this, we conducted a prospective, single-center, open-label, single-arm study to evaluate the safety and effectiveness of the device in patients with primary open-angle glaucoma (POAG) in our region.
Setting
Singapore National Eye Centre, a tertiary care eye hospital
Methods
A total of 30 eyes were followed up for 6-months at the Singapore National Eye Centre. The study assessed changes in IOP and medication usage compared to baseline at 6 months. Safety outcomes, including adverse events and additional glaucoma surgeries, were evaluated.
Results
13 subjects underwent combined surgery (PRESERFLO® and MMC with phacoemulsification) while 7 eyes received the PRESERFLO® MicroShunt and MMC as a standalone procedure. Mean age for combined surgery was 77.71 years, and for standalone procedure was 72 years. Baseline mean IOP was 16.1 mmHg for combined group and 18.1 mmHg for standalone procedure. At 6 months postoperative, mean IOP decreased to 12.9 mmHg for combined group and 13.0 mmHg for the PRESERFLO® MicroShunt alone group, with no patients in either group requiring glaucoma medication. Early post op complications: corneal folds in 4 cases, hyphema in 5 cases, hypotony with shallow AC in 2 cases and AC inflammation in 2 cases- all resolved promptly without visual morbidity.
Conclusions
This report provides valuable real-world data on the PRESERFLO® MicroShunt Glaucoma Device when used combined with cataract surgery or standalone in Asian eyes. The results indicate sustained and significant reductions in IOP and medication for up to 6 months postoperatively, with no significant safety concerns. These findings echo the effectiveness and safety of the PRESERFLO® MicroShunt Glaucoma Device with MMC in managing POAG in Asian eyes.