Status:
COMPLETED
The AVB Study: Prospective Study Comparing the Ahmed Valve and the Baerveldt Implant for Treating Refractory Glaucoma
Lead Sponsor:
Credit Valley EyeCare
Collaborating Sponsors:
Glaucoma Research Society of Canada
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ce...
Detailed Description
Introduction: The use of a glaucoma drainage device (GDD) is indicated in cases of refractory glaucoma not responsive to conventional medication, laser and surgical therapy. Most of these patients ar...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18.
- Inadequately controlled glaucoma determined as intraocular pressure (IOP) greater than target, which has not responded to conventional medical and surgical therapy.
- Patients with significant conjunctival scarring or high-risk disease (active neovascular glaucoma) precluding antimetabolite trabeculectomy will be included in the study.
- Provide written informed consent to participate in the study.
Exclusion
- Age less than 18.
- Patient will undergo an additional procedure at the time of glaucoma drainage device implantation (i.e. lensectomy, penetrating keratoplasty)
- No light perception vision.
- Patient has already been enrolled in the study in the contralateral eye.
- Patient is unwilling or unable to provide informed consent to participate in the study, or adhere to the study requirements including implant randomization and required follow-up visits.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00940823
Start Date
July 1 2005
End Date
April 1 2015
Last Update
March 13 2018
Active Locations (6)
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1
Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, United States, 46202
2
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
3
Drs. Massaro and Kalenak
Milwaukee, Wisconsin, United States, 53226
4
Credit ValleyEC
Toronto, Ontario, Canada, L5L 1W8