An investigator-initiated 10-participant Feasibility Study to assess a novel glaucoma drainage implant, VW-50.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Implantation of VW-50 (alone or in combination with cataract surgery)
Melbourne Eye Specialists
Fitzroy, Victoria, Australia
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 feasibility outcome 1
Duration of surgical implantation (mean, in minutes, excluding time for cataract extraction \& IOL insertion)
Time frame: 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)
Time frame: 12 months
Safety and tolerability outcome 1
Incidence of all adverse events
Time frame: 12 months
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
Safety and tolerability outcome 3
Best-corrected visual acuity (change compared to baseline)
Time frame: 12 months
Safety and tolerability outcome 4
Corneal endothelial cell density measured by Specular microscopy (mean change from baseline)
Time frame: 12 months
Efficacy outcome 1
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Mean Intraocular pressure (IOP) reduction at each post-operative timepoint and study conclusion, in mmHg
Time frame: 12 months
Efficacy outcome 2
Reduction in concomitant IOP-lowering medications at each post-operative timepoint and study conclusion (number of medications).
Time frame: 12 months