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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.
Full 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.
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Inclusion and exclusion criteria
Key Inclusion Criteria: Glaucoma in the study eye, meeting the following requirements:
i. Failure of medical treatment: inadequate IOP control on maximum tolerated medical therapy.
ii. Failure of previous glaucoma surgery (not more than one operation) with trabeculectomy, Xen/PreserFlo, non-penetrating glaucoma surgery, a previously removed suprachoroidal drainage device, trabecular bypass (using iStents or Hydrus), or cilioablation.
c. The mean diurnal IOP at Screening/Baseline is ≥ 20 mmHg, and ≤ 40 mmHg.
d. The conjunctiva in the target quadrant is healthy, mobile and suitable for glaucoma surgery.
Key Exclusion Criteria: in the study eye:
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65 participants in 1 patient group
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Central trial contact
Andrew Batty
Data sourced from clinicaltrials.gov
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