Tiny implant could ease glaucoma pressure
NCT ID NCT06176170
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called the VividWhite Glaucoma Implant, which is surgically placed in the eye to help lower pressure in people with glaucoma. Sixty-five participants will be followed for 12 months to see if the implant safely reduces eye pressure and lessens the need for medication. The goal is to offer a long-term treatment option for this common eye condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VividWhite Glaucoma Implant (VW-51) – a small device surgically placed in the eye to help drain fluid and lower pressure.
- What this could lead to
- If successful, this implant could provide a new way to control eye pressure and reduce the need for daily eye drops in people with glaucoma.
- What could go wrong
- This is a small, early-stage study with no comparison group, so results may not apply to everyone. The implant could cause side effects like infection or require additional surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: Glaucoma in the study eye, meeting the following requirements: 1. 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). 2. There has been failure of previous treatment for glaucoma (it is 'refractory'), meeting ONE of 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: 1. Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator. 2. 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. 3. 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. 4. 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. 5. Central corneal endothelial cell density less than specified age-related thresholds at screening. 6. Intraocular silicone oil. 7. Significant corneal, retinal, inflammatory or infective ophthalmic pathology (full details specified in the protocol).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cataract & Eye Surgery Centre
Doncaster East, Victoria, 3109, Australia
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Cerulea Clinical Trials, Centre for Eye Research Australia
East Melbourne, Victoria, 3002, Australia
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Eye Surgery Associates
Vermont South, Victoria, 3133, Australia
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Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
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Melbourne Eye Specialists
Fitzroy, Victoria, 3065, Australia
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Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise shield the eyes of glaucoma patients?
- One operation for cataract and glaucoma? eye surgeons test a Two-in-One approach
- Can better Follow-Up schedules save sight in glaucoma?
- Portable devices could take the guesswork out of eye pressure checks
- Eye drops may shield the cornea after cataract surgery
- Can a puff of air replace the eye pressure probe?