VividFlo System Validation Study

A prospective, single-centre, multi-surgeon, non-comparative clinical study where all participants undergo treatment with a surgical implant (VividFlo) and receive 12 months of follow-up. The intervention is surgical implantation of the VividFlo Glaucoma Implant (VW-51), using the VividFlo System for dissection, mitomycin-C administration and device insertion, and a partial thickness scleral flap over the device stem. The VividFlo System comprises VividFlo and accessory instruments, and is an integrated surgical solution designed to enable precise and reproducible implantation of VividFlo. The aims of this study are to assess the safety and technical skill required for a partial-thickness scleral flap implantation technique; the usability, performance and suitability of the VividFlo System; and the safety and effectiveness of VividFlo.