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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)

NCT00834223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2011-04-01

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Aquashunt

A shunt which is implanted into the suprachoroidal space.

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Naveen Shams, MD PhD · Opko Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-09-30
Completion
2010-05-31

Countries

  • Dominican Republic

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00834223 on ClinicalTrials.gov