NCT06176170

VividWhite Glaucoma Implant (VW-51) Pivotal Study

A Prospective Multicentre Pivotal Clinical Study to Demonstrate the Efficacy and Safety of the VividWhite Glaucoma Implant (VW-51) for the Treatment of Glaucoma.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: VividWhite Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The VividWhite Glaucoma Implant (VW-51) is a novel surgical implant designed to treat glaucoma. This study is a 12-month, 65-participant non-comparative multicentre study to assess the safety and effectiveness of the VW-51 implant.

Detailed description

A prospective multicentre non-comparative pivotal clinical study where all participants undergo treatment with a novel surgical implant (VW-51) and receive 12 months of clinical follow-up. The study aim is to assess the effectiveness, safety and participant experience of the VW-51 implant for the treatment of glaucoma. The study population will involve 65 adult participants with medically or surgically refractory glaucoma. The VW-51 implant is a leaf-shaped microfluidic device manufactured from flexible silicone, designed to be surgically implanted in the subconjunctival space, drain aqueous humor from the eye and reduce intraocular pressure to treat glaucoma.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	VividWhite Glaucoma Implant (VW-51)	Subconjunctival surgical implantation of the VW-51 implant in the study eye.

Timeline

• Start date: 2023-12-12
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2023-12-19
• Last updated: 2025-11-18

Locations

6 sites across 1 country: Australia