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GlaucomaNCT07754201

VividFlo System Validation Study

A study testing VividFlo System in people with Glaucoma, run by VividWhite Pty Ltd at 1 site in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a 10-participant study to assess the VividFlo System and surgical implantation using a modified technique. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma
What is being tested?
VividFlo System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteAustralia
Study dates
10 Aug 2026to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age, Capacity \& Consent:
  • Be 18 years of age or older.
  • Be able to understand all study instructions, and willing to comply with all study procedures and the visit schedule.
  • Provide written, informed consent to participate.
  • Glaucoma in the study eye, meeting all of the following requirements:
  • Diagnosed by the investigator, based upon untreated intraocular pressure, disc appearance and visual field abnormalities.
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  • The glaucoma type is one of:
  • Primary open angle glaucoma (POAG). ii. Chronic angle closure glaucoma (CACG) where the eye is pseudophakic. iii. Mixed mechanism POAG/CACG where a laser iridotomy has previously been performed.
  • Pigmentary open angle glaucoma. v. Exfoliation open angle glaucoma. vi. Neovascular glaucoma that is treated and regressed/quiescent. c. Glaucoma drainage surgery is indicated due to failure of previous treatment (the glaucoma is 'refractory'), with failure of maximum tolerated medical therapy and one of the following circumstances: i. No previous glaucoma surgery. ii. Prior trabecular bypass (using iStents or Hydrus) or cilioablation. iii. Failure of one prior glaucoma drainage operation (that is one of trabeculectomy, deep sclerectomy or Xen).
  • The mean diurnal IOP at Baseline is greater than or equal to 20 mmHg and less than or equal to 40 mmHg.
  • The conjunctiva in the target quadrant is suitable for glaucoma surgery.

Who cannot join

  • 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 (CACG) where the eye is phakic.
  • Congenital glaucoma. Juvenile Open-Angle Glaucoma or Congenital Glaucoma.
  • Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma.
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  • Previous glaucoma surgery with:
  • A tube-and-plate glaucoma drainage implant (GDI, e.g. Molteno, Baerveldt, Paul).
  • A suprachoroidal implant.
  • Multiple previous operations for glaucoma.
  • Glaucoma surgery within 3 months of screening.
  • 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.
  • Conjunctival scarring or pterygium in the target quadrant.
  • Severe dry eye disease.
  • Significant corneal disease.
  • Accurate measurement of baseline central corneal endothelial density is not possible.
  • Any treatment or condition that, in the opinion of the investigator, may impact corneal endothelial cell density beyond expected age \& disease-related decline.
  • Significant retinal or posterior segment pathology, including but not limited to:
  • Active and clinically significant diabetic retinopathy.
  • Active choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy.
  • Intraocular silicone oil.
  • Presence of a scleral buckle.
  • Vitreous present in the anterior chamber.
  • Active uveitis or clinically significant infection or inflammation.
  • Unfit for surgery under local anaesthetic.
  • Any uncontrolled systemic disease.
  • The participant is pregnant, breastfeeding, or cannot guarantee they will not conceive or donate sperm or eggs during the study.
  • Significant risk of bleeding.
  • Any other clinical or social reason that, in the opinion of the investigator, means standard surgical treatment for glaucoma would be considered safer than participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew Batty contact

+61 418 213 895

contact@vividwhite.com.au

Australia1 site

  • Melbourne Eye Specialists

    Fitzroy, Victoria, 3065

    Michael Coote, +61 3 9417 1055, reception@melbeye.com.au

    Michael Coote

Other trials in Australia

About this study

Official title: A Prospective Evaluation of the Safety and Effectiveness of VividFlo Implantation Using a Partial-Thickness Scleral Flap Technique and The VividFlo System.

This is a 10-participant study to assess the VividFlo System and surgical implantation using a modified technique.

Read the detailed description

A prospective, single-centre, multi-surgeon, non-comparative clinical study where all participants undergo treatment with a surgical implant (VividFlo) and receive 12 months of follow-up. The intervention is surgical implantation of the VividFlo Glaucoma Implant (VW-51), using the VividFlo System for dissection, mitomycin-C administration and device insertion, and a partial thickness scleral flap over the device stem. The VividFlo System comprises VividFlo and accessory instruments, and is an integrated surgical solution designed to enable precise and reproducible implantation of VividFlo. The aims of this study are to assess the safety and technical skill required for a partial-thickness scleral flap implantation technique; the usability, performance and suitability of the VividFlo System; and the safety and effectiveness of VividFlo.

Conditions
Glaucoma
Being tested
VividFlo System
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VividFlo SystemDevice

    Subconjunctival surgical implantation of the VividFlo Glaucoma Implant (VW-51) in one eye using the VividFlo System and a partial-thickness scleral flap technique.

Study groups in NCT07754201
Study groupRoleWhat they receive
VividFlo SystemExperimentalSurgical implantation of VividFlo.
Receives: Device: VividFlo System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome

    The proportion of study eyes that meet all the following criteria:

    1. Mean diurnal IOP at 12 months is: <=21 mmHg; and >=6 mmHg; and reduced by >=20% compared to baseline.
    2. The number of topical IOP-lowering medications at 12 months is the same or fewer than at baseline.
    3. At any time during the study, there has been no requirement for: further glaucoma surgery (indicated for efficacy or safety); or systemic/oral IOP-lowering medication for treatment of elevated IOP in the study eye.
    4. There have been no adverse events of special significance, defined as: conjunctival erosion; loss of light perception or reduction in best-corrected visual acuity equivalent to doubling of minimum angle of resolution; >=20% reduction in mean retinal nerve fibre layer attributed to glaucoma; >=20% reduction in central corneal endothelial cell density attributed to the implant; or Uveitis, Glaucoma and Hyphaema Syndrome.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start10 Aug 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07754201
Sponsor's protocol ID
DF-570
Status last verified
Aug 2026
First submitted
4 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VividFlo System in people with Glaucoma, run by VividWhite Pty Ltd at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew Batty (+61 418 213 895, contact@vividwhite.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07754201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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VividFlo System Validation Study (NCT07754201) | AzTrials