NCT06176170Active, not recruiting
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.
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 10 Dec 2023
- Start date
- 12 Dec 2023
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- VividWhite Pty Ltd
- Diseases
- Glaucoma
- NCT number
- NCT06176170
What you commit to
- Study type: Interventional
- Planned participants: 65
- From 12 Dec 2023 to the primary completion date, 31 Oct 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Age
- Central corneal endothelial cell density less than specified age-related thresholds at screening.
Other
- Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.
- Intraocular silicone oil.
- Significant corneal, retinal, inflammatory or infective ophthalmic pathology (full details specified in the protocol).
Who the study is looking for
- 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:
- Failure of medical treatment: inadequate IOP control on maximum tolerated medical therapy.
- 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.
- The mean diurnal IOP at Screening/Baseline is ≥ 20 mmHg, and ≤ 40 mmHg.
- The conjunctiva in the target quadrant is healthy, mobile and suitable for glaucoma surgery.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Cataract & Eye Surgery Centre Coordinator of this site? Confirm its status | Doncaster East | Australia | Unknown status |
| Cerulea Clinical Trials, Centre for Eye Research Australia Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Melbourne Eye Specialists Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Sydney Eye Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Eye Surgery Associates Coordinator of this site? Confirm its status | Vermont South | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.