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CompletedNCT07730424Updated Jul 28, 2026

VW-50 Feasibility Study

An interventional study of Surgical implantation of VW-50 in Glaucoma, sponsored by Melbourne Eye Specialists. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Melbourne Eye Specialists · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Aug 2022, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Glaucoma

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 10 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

This is the only study on the registry with Melbourne Eye Specialists as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    VW-50

    VW-50 glaucoma implant

    Device: Surgical implantation of VW-50

Interventions

  • DeviceSurgical implantation of VW-50

    Implantation of VW-50 (alone or in combination with cataract surgery)

06

What researchers measure

Primary outcomes

  1. 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')

    Time frame: At study intervention

Secondary outcomes

  1. Secondary feasibility outcome 1

    Duration of surgical implantation (mean, in minutes, excluding time for cataract extraction \& IOL insertion)

    Time frame: At study intervention

  2. Secondary feasibility outcome 2

    Confirmation that VW-50 entry cannula was inserted into the anterior chamber (binary outcome with gonioscopy photograph evidence)

    Time frame: 12 months

  3. Safety and tolerability outcome 1

    Incidence of all adverse events

    Time frame: 12 months

  4. Safety and tolerability outcome 2

    Participant ocular quality of life assessed by 7-item local symptoms component of the SHPC-18 questionnaire

    Time frame: 12 months

  5. Safety and tolerability outcome 3

    Best-corrected visual acuity (change compared to baseline)

    Time frame: 12 months

  6. Safety and tolerability outcome 4

    Corneal endothelial cell density measured by Specular microscopy (mean change from baseline)

    Time frame: 12 months

  7. Efficacy outcome 1

    Mean Intraocular pressure (IOP) reduction at each post-operative timepoint and study conclusion, in mmHg

    Time frame: 12 months

  8. Efficacy outcome 2

    Reduction in concomitant IOP-lowering medications at each post-operative timepoint and study conclusion (number of medications).

    Time frame: 12 months

07

Study locations

1 site
  • Melbourne Eye Specialists
    Fitzroy, Victoria 3065, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07730424
Lead sponsor
Melbourne Eye Specialists
Responsible party
Sponsor
First posted
Jul 28, 2026
Start date
Aug 4, 2022
Primary completion
Oct 17, 2023
Completion
Oct 17, 2023
Last update
Jul 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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