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Completed

NCT Number: NCT07730424

VW-50 Feasibility Study

An investigator-initiated 10-participant Feasibility Study to assess a novel glaucoma drainage implant, VW-50.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Melbourne Eye Specialists

Fitzroy, Victoria, 3065, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical implantation of VW-50

Device

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

Primary outcomes

  1. 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')

Secondary outcomes

  1. Secondary feasibility outcome 1

    Time frame: At study intervention

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

  2. Secondary feasibility outcome 2

    Time frame: 12 months

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

  3. Safety and tolerability outcome 1

    Time frame: 12 months

    Incidence of all adverse events

  4. Safety and tolerability outcome 2

    Time frame: 12 months

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

  5. Safety and tolerability outcome 3

    Time frame: 12 months

    Best-corrected visual acuity (change compared to baseline)

  6. Safety and tolerability outcome 4

    Time frame: 12 months

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

  7. Efficacy outcome 1

    Time frame: 12 months

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

  8. Efficacy outcome 2

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Melbourne Eye Specialists

Network

Registry information

Official study title

A Feasibility Clinical Study to Evaluate the Safety and Effectiveness of the VividWhite Glaucoma Implant (VW-50) for the Treatment of Glaucoma.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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