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Completed NCT07730424

VW-50 Feasibility Study

Conditions: Glaucoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Melbourne Eye Specialists

Location: Melbourne Eye Specialists Fitzroy Victoria

Summary

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07730424). StuddyBuddy aggregates publicly available trial information.