A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)
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|ClinicalTrials.gov Identifier: NCT00834223|
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : April 1, 2011
|Condition or disease||Intervention/treatment|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)|
|Study Start Date :||January 2009|
|Primary Completion Date :||September 2009|
|Study Completion Date :||May 2010|
Open label, all subjects receive device.
A shunt which is implanted into the suprachoroidal space.
- Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation. [ Time Frame: 6 and 12 months ]
- Secondary efficacy measure: The change in the number of glaucoma medications from baseline at 6 and 12 months post-implantation. [ Time Frame: 6 and 12 months ]
- Safety measures: The incidence of device and procedure-related complications. All adverse events reported, whether deemed related to the treatment or not. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834223
|Santo Domingo, Dominican Republic|
|Study Director:||Naveen Shams, MD PhD||Opko Health|