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)

OPKO Health, Inc.1 site in 1 country15 target enrollmentJanuary 2009

ConditionsGlaucoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glaucoma
Sponsor: OPKO Health, Inc.
Enrollment: 15
Locations: 1
Primary Endpoint: Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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). The primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after implantation in patients with refractory chronic forms of OAG

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

May 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

OPKO Health, Inc.

Eligibility Criteria

Inclusion Criteria

•Patients of either sex will be eligible for the study if all of the following criteria are met:
•Patients must be aged 18 years or more.
•Patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery.
•The patient's documented IOP must be considered by the treating physician to be too high for their glaucoma status.
•Patients must have BCVA of between 20/400 and Light Perception, or no light perception with pain, in the study eye.
•Patients must have a BCVA in the fellow eye, which is better than that of the study eye.
•Patients must be mentally competent and willing to provide informed consent.
•Patients must be willing to return for all study visits and assessments for at least 3 years after surgery.
•Exclusion Criteria
•Patients will not be eligible for the study if any of the following criteria are present:

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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 Outcomes

Secondary efficacy measure: The change in the number of glaucoma medications from baseline at 6 and 12 months post-implantation.(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.(3 years)