VividFlo System Validation Study

NCT07754201 | Not Yet Recruiting DMC

• 1 other identifier: DF-570
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (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.

  12 months

Study Arms (1)

VividFlo System

EXPERIMENTAL

Surgical implantation of VividFlo.

Device: VividFlo System

Interventions

VividFlo System DEVICE

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

VividFlo System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The glaucoma type is one of:
• i. 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.
• iv. 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).
• d. The mean diurnal IOP at Baseline is greater than or equal to 20 mmHg and less than or equal to 40 mmHg.
• e. The conjunctiva in the target quadrant is suitable for glaucoma surgery.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• VividWhite Pty Ltd: lead

Study Sites (1)

Melbourne Eye Specialists

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Michael Coote

  Melbourne Eye Specialists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Batty

CONTACT

+61 418 213 895; contact@vividwhite.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)