VividWhite Glaucoma Implant (VW-51) Pivotal Study

Korábbi kezelés

• Previous glaucoma surgery with: a tube-and-plate glaucoma drainage device (GDD, e.g. Molteno, Baerveldt, Ahmed, Schocket); an in-situ suprachoroidal implant; or multiple previous operations for glaucoma.
• 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.

Más betegség

• The glaucoma type is any of the following: Acute Angle Closure Glaucoma (AACG); Chronic Angle Closure Glaucoma where the eye is phakic; Congenital glaucoma; or Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular/rubeotic glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma.

Életkor

• Central corneal endothelial cell density less than specified age-related thresholds at screening.

Egyéb

• Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.
• Intraocular silicone oil.
• Significant corneal, retinal, inflammatory or infective ophthalmic pathology (full details specified in the protocol).

• Glaucoma is diagnosed by the investigator based upon untreated intraocular pressure, disc appearance and visual field abnormalities, and where the disease type is one of: Primary open angle glaucoma (POAG); Chronic angle closure glaucoma (CACG) where the eye is pseudophakic and a laser iridotomy has previously been performed; Pigmentary open angle glaucoma; Exfoliation open angle glaucoma; Rubeotic glaucoma that is treated and regressed/quiescent; Steroid-induced glaucoma; or Juvenile open angle glaucoma (JOAG).
• There has been failure of previous treatment for glaucoma (it is 'refractory'), meeting ONE of the following requirements:
• Failure of medical treatment: inadequate IOP control on maximum tolerated medical therapy.
• Failure of previous glaucoma surgery (not more than one operation) with trabeculectomy, Xen/PreserFlo, non-penetrating glaucoma surgery, a previously removed suprachoroidal drainage device, trabecular bypass (using iStents or Hydrus), or cilioablation.
• The mean diurnal IOP at Screening/Baseline is ≥ 20 mmHg, and ≤ 40 mmHg.
• The conjunctiva in the target quadrant is healthy, mobile and suitable for glaucoma surgery.