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

Glaucoma Clinical Trial

Official title:
Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments

Clinical Trial Summary

Study Objective:

To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00382395
Study type Interventional
Source SOLX, Inc.
Contact
Status Suspended
Phase Phase 3
Start date November 2005
Completion date July 2017
View Details
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