GlaucomaNCT07730424
VW-50 Feasibility Study
A study testing Surgical implantation of VW-50 in people with Glaucoma, run by Melbourne Eye Specialists at 1 site in Australia.
Trial summary
An investigator-initiated 10-participant Feasibility Study to assess a novel glaucoma drainage implant, VW-50. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Surgical implantation of VW-50
- 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
- 4 Aug 2022to 17 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 - greater than 18 years of age.
- Glaucoma - as diagnosed by the investigator based upon untreated intraocular pressure, disc appearance, and visual field abnormalities.
- Failed medical treatment - In the opinion of the investigator, the IOP is uncontrolled in the study eye after having failed previous medical treatment.
- Conjunctival health - In the opinion of the investigator the participant should have a healthy, free, and mobile conjunctiva in the target quadrant.
- Capable - Ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.
Who cannot join
- Prior glaucoma surgery in the study eye.
- Advanced glaucomatous optic nerve damage which, in the opinion of the investigator, threatens fixation and/or standard surgery would be considered safer.
- Active neovascular glaucoma, Iridocorneal Endothelial (ICE) Syndrome, traumatic glaucoma, silicone oil induced glaucoma, active acute angle closure glaucoma or subluxation of the lens.
- Active diabetic retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy, or other ophthalmic disease or disorder in the study eye that could confound study results.
- Any condition of the cornea that could confound study results or would preclude accurate readings with an applanation tonometer and/or a contact pachymeter.
- Visually significant cataract in the study eye that will not be removed at the time of implantation.
Show all 12Show fewer
- BCVA worse than 6/30 (Snellen equivalent)
- Clinically significant inflammation or infection in either eye
- Unfit for local anaesthetic surgery.
- Any uncontrolled systemic disease.
- Female participants who are pregnant, nursing, or planning a pregnancy during the study, or who are of childbearing potential and not using a reliable means of contraception during the study.
- Significant risk of bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Clinical Study to Evaluate the Safety and Effectiveness of the VividWhite Glaucoma Implant (VW-50) for the Treatment of Glaucoma.
An investigator-initiated 10-participant Feasibility Study to assess a novel glaucoma drainage implant, VW-50.
Read the detailed description
A single-centre, investigator-initiated device Feasibility Study where 10 participants undergo glaucoma surgery for implantation of a novel implant (VW-50) and receive 12 months of follow-up.
- Conditions
- Glaucoma
- Being tested
- Surgical implantation of VW-50
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical implantation of VW-50Device
Implantation of VW-50 (alone or in combination with cataract surgery)
| Study group | Role | What they receive |
|---|---|---|
| VW-50 | Experimental | VW-50 glaucoma implant Receives: Device: Surgical implantation of VW-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary feasibility outcome
Assessment of the ease of implantation of VW-50 in the human eye, measured by surgeon questionnaire assessment of implantation technique (custom 11-item questionnaire with 5 responses selectable per item, ranging from 'strongly disagree' to 'strongly agree')
Measured: At study intervention
Secondary outcomes (8)
Secondary feasibility outcome 1
Duration of surgical implantation (mean, in minutes, excluding time for cataract extraction \& IOL insertion)
Measured: At study intervention
Secondary feasibility outcome 2
Confirmation that VW-50 entry cannula was inserted into the anterior chamber (binary outcome with gonioscopy photograph evidence)
Measured: 12 months
Safety and tolerability outcome 1
Incidence of all adverse events
Measured: 12 months
Safety and tolerability outcome 2
Participant ocular quality of life assessed by 7-item local symptoms component of the SHPC-18 questionnaire
Measured: 12 months
Safety and tolerability outcome 3
Best-corrected visual acuity (change compared to baseline)
Measured: 12 months
Safety and tolerability outcome 4
Corneal endothelial cell density measured by Specular microscopy (mean change from baseline)
Measured: 12 months
Efficacy outcome 1
Mean Intraocular pressure (IOP) reduction at each post-operative timepoint and study conclusion, in mmHg
Measured: 12 months
Efficacy outcome 2
Reduction in concomitant IOP-lowering medications at each post-operative timepoint and study conclusion (number of medications).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start4 Aug 2022
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Eye Specialists
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730424
- Sponsor's protocol ID
- DF-450
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Clinical Study to Evaluate the Safety and Effectiveness of the VividWhite Glaucoma Implant (VW-50) for the Treatment of Glaucoma.
- ClinicalTrials.gov ID
- NCT07730424
- Acronym / sponsor ID
- DF-450
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Melbourne Eye SpecialistsResearch network
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An investigator-initiated 10-participant Feasibility Study to assess a novel glaucoma drainage implant, VW-50.
Detailed description
A single-centre, investigator-initiated device Feasibility Study where 10 participants undergo glaucoma surgery for implantation of a novel implant (VW-50) and receive 12 months of follow-up.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VW-50 | Experimental | Device: Surgical implantation of VW-50VW-50 glaucoma implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age - greater than 18 years of age.
- Glaucoma - as diagnosed by the investigator based upon untreated intraocular pressure, disc appearance, and visual field abnormalities.
- Failed medical treatment - In the opinion of the investigator, the IOP is uncontrolled in the study eye after having failed previous medical treatment.
- Conjunctival health - In the opinion of the investigator the participant should have a healthy, free, and mobile conjunctiva in the target quadrant.
- Capable - Ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.
Key exclusion criteria (12 listed)
- Prior glaucoma surgery in the study eye.
- Advanced glaucomatous optic nerve damage which, in the opinion of the investigator, threatens fixation and/or standard surgery would be considered safer.
- Active neovascular glaucoma, Iridocorneal Endothelial (ICE) Syndrome, traumatic glaucoma, silicone oil induced glaucoma, active acute angle closure glaucoma or subluxation of the lens.
- Active diabetic retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy, or other ophthalmic disease or disorder in the study eye that could confound study results.
- Any condition of the cornea that could confound study results or would preclude accurate readings with an applanation tonometer and/or a contact pachymeter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical implantation of VW-50Implantation of VW-50 (alone or in combination with cataract surgery) | Device | VW-50 |
Primary outcome
Primary feasibility outcome
Time frame: At study intervention
Assessment of the ease of implantation of VW-50 in the human eye, measured by surgeon questionnaire assessment of implantation technique (custom 11-item questionnaire with 5 responses selectable per item, ranging from 'strongly disagree' to 'strongly agree')
8 secondary outcomes
Secondary feasibility outcome 1
Time frame: At study intervention
Secondary feasibility outcome 2
Time frame: 12 months
Safety and tolerability outcome 1
Time frame: 12 months
Safety and tolerability outcome 2
Time frame: 12 months
Safety and tolerability outcome 3
Time frame: 12 months
Safety and tolerability outcome 4
Time frame: 12 months
Efficacy outcome 1
Time frame: 12 months
Efficacy outcome 2
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical implantation of VW-50 in people with Glaucoma, run by Melbourne Eye Specialists 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 28 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary feasibility outcome (time frame: At study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.