Glaucoma
Conditions
Brief summary
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.
Interventions
DEVICESurgical implantation of VW-50
Implantation of VW-50 (alone or in combination with cataract surgery)
Sponsors
Melbourne Eye Specialists
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary feasibility outcome | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary feasibility outcome 1 | At study intervention | Duration of surgical implantation (mean, in minutes, excluding time for cataract extraction \& IOL insertion) |
| Secondary feasibility outcome 2 | 12 months | Confirmation that VW-50 entry cannula was inserted into the anterior chamber (binary outcome with gonioscopy photograph evidence) |
| Safety and tolerability outcome 1 | 12 months | Incidence of all adverse events |
| Safety and tolerability outcome 2 | 12 months | Participant ocular quality of life assessed by 7-item local symptoms component of the SHPC-18 questionnaire |
| Safety and tolerability outcome 3 | 12 months | Best-corrected visual acuity (change compared to baseline) |
| Safety and tolerability outcome 4 | 12 months | Corneal endothelial cell density measured by Specular microscopy (mean change from baseline) |
| Efficacy outcome 1 | 12 months | Mean Intraocular pressure (IOP) reduction at each post-operative timepoint and study conclusion, in mmHg |
| Efficacy outcome 2 | 12 months | Reduction in concomitant IOP-lowering medications at each post-operative timepoint and study conclusion (number of medications). |
Countries
Australia
Outcome results
None listed