This is a 10-participant study to assess the VividFlo System and surgical implantation using a modified technique.
A prospective, single-centre, multi-surgeon, non-comparative clinical study where all participants undergo treatment with a surgical implant (VividFlo) and receive 12 months of follow-up. The intervention is surgical implantation of the VividFlo Glaucoma Implant (VW-51), using the VividFlo System for dissection, mitomycin-C administration and device insertion, and a partial thickness scleral flap over the device stem. The VividFlo System comprises VividFlo and accessory instruments, and is an integrated surgical solution designed to enable precise and reproducible implantation of VividFlo. The aims of this study are to assess the safety and technical skill required for a partial-thickness scleral flap implantation technique; the usability, performance and suitability of the VividFlo System; and the safety and effectiveness of VividFlo.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Subconjunctival surgical implantation of the VividFlo Glaucoma Implant (VW-51) in one eye using the VividFlo System and a partial-thickness scleral flap technique.
Melbourne Eye Specialists
Fitzroy, Victoria, Australia
Primary Outcome
The proportion of study eyes that meet all the following criteria: 1. Mean diurnal IOP at 12 months is: \<=21 mmHg; and \>=6 mmHg; and reduced by \>=20% compared to baseline. 2. The number of topical IOP-lowering medications at 12 months is the same or fewer than at baseline. 3. At any time during the study, there has been no requirement for: further glaucoma surgery (indicated for efficacy or safety); or systemic/oral IOP-lowering medication for treatment of elevated IOP in the study eye. 4. There have been no adverse events of special significance, defined as: conjunctival erosion; loss of light perception or reduction in best-corrected visual acuity equivalent to doubling of minimum angle of resolution; \>=20% reduction in mean retinal nerve fibre layer attributed to glaucoma; \>=20% reduction in central corneal endothelial cell density attributed to the implant; or Uveitis, Glaucoma and Hyphaema Syndrome.
Time frame: 12 months
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