Active — Not RecruitingNot Applicable

VividWhite Glaucoma Implant (VW-51) Pivotal Study

Australia65 participantsStarted 2023-12-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Glaucoma is diagnosed by the investigator based upon untreated intraocular pressure, disc appearance and visual field abnormalities, and where the disease type is one of: Primary open angle glaucoma (POAG); Chronic angle closure glaucoma (CACG) where the eye is pseudophakic and a laser iridotomy has previously been performed; Pigmentary open angle glaucoma; Exfoliation open angle glaucoma; Rubeotic glaucoma that is treated and regressed/quiescent; Steroid-induced glaucoma; or Juvenile open angle glaucoma (JOAG).
✓. There has been failure of previous treatment for glaucoma (it is 'refractory'), meeting ONE of the following requirements:

Exclusion criteria

✕. Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.
✕. The glaucoma type is any of the following: Acute Angle Closure Glaucoma (AACG); Chronic Angle Closure Glaucoma where the eye is phakic; Congenital glaucoma; or Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular/rubeotic glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma.
✕. Previous glaucoma surgery with: a tube-and-plate glaucoma drainage device (GDD, e.g. Molteno, Baerveldt, Ahmed, Schocket); an in-situ suprachoroidal implant; or multiple previous operations for glaucoma.
✕. Cataract surgery or any other ocular surgery is indicated at the time of study intervention or is anticipated to be required during the study duration.
✕. Central corneal endothelial cell density less than specified age-related thresholds at screening.
✕. Intraocular silicone oil.
✕. Significant corneal, retinal, inflammatory or infective ophthalmic pathology (full details specified in the protocol).

What they're measuring

Complete success by efficacy and safety criteria

Timeframe: Study completion (12 months)

Trial details

NCT IDNCT06176170

SponsorVividWhite Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Glaucoma trials