The AVB Study: Prospective Study Comparing the Ahmed Valve and the Baerveldt Implant for Treating Refractory Glaucoma

Summary

The purpose of this study is to compare the safety and efficacy of the Ahmed valve and the Baerveldt implant in treating refractory glaucoma. Eligible patients will be recruited from multiple study centers and randomized to a glaucoma drainage device for implantation. They will be followed long-term based upon outcome measures including intraocular pressure, glaucoma medication use, visual acuity, complications of the surgery and further treatments required.

Conditions

• Glaucoma

Interventions

DEVICE

Ahmed FP7 Valve

Implantation of Ahmed FP7 Valve to lower intraocular pressure in refractory glaucoma.

DEVICE

Baerveldt-350 Tube

Implantation of Baerveldt-350 Tube to lower intraocular pressure in refractory glaucoma.

Sponsors & Collaborators

• Glaucoma Research Society of Canada

  collaborator OTHER

• Credit Valley EyeCare

  lead INDUSTRY

Principal Investigators

• Iqbal K Ahmed, MD · University of Toronto Department of Ophthalmology & Vision Sciences

• Panos G Christakis, BS · Yale University

• James C Tsai, MD · Yale Ophthalmology & Visual Science

• Jeffrey W Kalenak, MD · Drs. Massaro & Kalenak, SC

• Louis B Cantor, MD · Department of Ophthalmology, Indiana University

• Jeffrey A Kammer, MD · Department of Ophthalmology and Visual Sciences: Vanderbilt University, School of Medicine

• Paul J Harasymowycz, MD · University of Montreal: Department of Ophthalmology

• Juan J Mura, MD · Clinic of Las Condes

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-07-31

Primary Completion

2014-04-30

Completion

2015-04-30

Countries

• United States
• Canada
• Chile

Study Locations