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

Launched by SOLX, INC. · Sep 27, 2006

Keywords

ClinConnect Summary

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 significan...

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Eligibility criteria

• 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