SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma

This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP
lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially
available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve
Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a
period not to exceed two years, should this be necessary for regulatory purposes. Follow-up
beyond one year will be expected unless other patients with SOLX Gold Shunt implants in
earlier phase studies outside the US clearly show no significant adverse effects associated
with the long-term use of the device for follow-up periods exceeding one year, and this
information is deemed adequate to reduce the required follow-up period under this protocol
to a shorter period, such as 6 months for the last-to-enter patients at the time of filing
for 510(k) marketing clearance review with the FDA.

Inclusion Criteria:

- Primary open-angle, pseudoexfoliative, or pigmentary glaucoma

- Age 21 or over

- refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional
glaucoma surgery

- detectable visual field defect (negative MD score)

- written consent

- available for up to 24 months follow-up

Exclusion Criteria:

- either eye with VA worse than count fingers

- recent angle closure glaucoma episode

- uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or
neovascular glaucoma

- other significant ocular disease, except cataract

- active ocular infection

- expected ocular surgery in next 12 months

- no suitable quadrant for implant

- systemic corticosteroid therapy > 5 mg/day prednisone

- intolerance to gonioscopy or other eye exams

- mental impairment interfering with consent or compliance

- pregnancy

- known sensitivity to anticipated medications used at surgery

- significant co-morbid disease

- concurrent enrollment in another drug or device study