VividFlo System Validation Study

Prior treatment

• 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.

Other illness

• 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.

Age

• Any treatment or condition that, in the opinion of the investigator, may impact corneal endothelial cell density beyond expected age \& disease-related decline.

Other

• 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.

• 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.