VividFlo System Validation Study

Ki vehet részt

• Age, Capacity \& Consent:; Be 18 years of age or older; Be able to understand all study instructions, and willing to comply with all study procedures and the visit schedule; Provide written, informed consent to participate
• Glaucoma in the study eye, meeting all of the following requirements:; Diagnosed by the investigator, based upon untreated intraocular pressure, disc appearance and visual field abnormalities; The glaucoma type is one of:; Primary open angle glaucoma (POAG). ii. Chronic angle closure glaucoma (CACG) where the eye is pseudophakic. iii. Mixed mechanism POAG/CACG where a laser iridotomy has previously been performed; Pigmentary open angle glaucoma. v. Exfoliation open angle glaucoma. vi. Neovascular glaucoma that is treated and regressed/quiescent. c. Glaucoma drainage surgery is indicated due to failure of previous treatment (the glaucoma is 'refractory'), with failure of maximum tolerated medical therapy and one of the following circumstances: i. No previous glaucoma surgery. ii. Prior trabecular bypass (using iStents or Hydrus) or cilioablation. iii. Failure of one prior glaucoma drainage operation (that is one of trabeculectomy, deep sclerectomy or Xen); The mean diurnal IOP at Baseline is greater than or equal to 20 mmHg and less than or equal to 40 mmHg; The conjunctiva in the target quadrant is suitable for glaucoma surgery

Ki nem vehet részt

• Previous glaucoma surgery with:; A tube-and-plate glaucoma drainage implant (GDI, e.g. Molteno, Baerveldt, Paul); A suprachoroidal implant; Multiple previous operations for glaucoma; Glaucoma surgery within 3 months of screening
• Cataract surgery or any other ocular surgery is indicated at the time of study intervention or is anticipated to be required during the study duration
• Unfit for surgery under local anaesthetic
• Any other clinical or social reason that, in the opinion of the investigator, means standard surgical treatment for glaucoma would be considered safer than participation in the study
• The glaucoma type is any of the following:; Acute Angle Closure Glaucoma (AACG); Chronic Angle Closure Glaucoma (CACG) where the eye is phakic; Congenital glaucoma. Juvenile Open-Angle Glaucoma or Congenital Glaucoma; Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma
• Severe dry eye disease
• Significant corneal disease
• Active uveitis or clinically significant infection or inflammation
• Any uncontrolled systemic disease
• Significant risk of bleeding
• Any treatment or condition that, in the opinion of the investigator, may impact corneal endothelial cell density beyond expected age \& disease-related decline
• Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator
• Conjunctival scarring or pterygium in the target quadrant
• Accurate measurement of baseline central corneal endothelial density is not possible
• Significant retinal or posterior segment pathology, including but not limited to:; Active and clinically significant diabetic retinopathy; Active choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy; Intraocular silicone oil; Presence of a scleral buckle
• Vitreous present in the anterior chamber
• The participant is pregnant, breastfeeding, or cannot guarantee they will not conceive or donate sperm or eggs during the study