The AVB Study: Prospective Study Comparing the Ahmed Valve and the Baerveldt Implant for Treating Refractory Glaucoma
|ClinicalTrials.gov Identifier: NCT00940823|
Recruitment Status : Completed
First Posted : July 16, 2009
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Device: Ahmed FP7 Valve Device: Baerveldt-350 Tube||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Ahmed Versus Baerveldt (AVB) Study: Prospective, Multicenter Trial Comparing the Ahmed-FP7 Valve With the Baerveldt-350 Implant in Treating Refractory Glaucoma|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2015|
Active Comparator: Ahmed FP7 Valve
Ahmed valve glaucoma drainage device implant for treatment of refractory glaucoma.
Device: Ahmed FP7 Valve
Implantation of Ahmed FP7 Valve to lower intraocular pressure in refractory glaucoma.
Active Comparator: Baerveldt-350 Tube
Baerveldt tube glaucoma drainage device implant for treatment of refractory glaucoma.
Device: Baerveldt-350 Tube
Implantation of Baerveldt-350 Tube to lower intraocular pressure in refractory glaucoma.
- Number of Participants With Surgical Failure (Composite Measure) [ Time Frame: 5 years ]
- IOP out of target range (5-18 mmHg inclusive) or <20% reduction from baseline for 2 consecutive visits after 3 months.
- De novo glaucoma surgery required (e.g., cyclodestructive procedure, additional tube shunt).
- Removal of the implant.
- Severe vision loss related to the surgery (endophthalmitis, suprachoroidal hemorrhage with vision loss, enucleation, evisceration, or phthisis bulbi) or progression to no light perception for any reason.
- Intraocular Pressure (IOP) [ Time Frame: 5 years ]
- Anti-glaucoma Medications [ Time Frame: 5 years ]
- LogMAR Snellen Visual Acuity [ Time Frame: 5 years ]Visual acuity (VA) was tested monocularly (one eye at a time) using the manifest refraction adjusted for optical infinity using a standard Snellen Visual Acuity chart at 20 feet. Normal vision, or 20/20 vision, means that the participant can see at 20 feet what a healthy control can also see at 20 feet. Legal blindness, or 20/200 vision, means the participant can see at 20 feet what a healthy control can see at 200 feet. Hence, an increasing denominator implies visual impairment. Counting fingers was designated as 20/2000 vision, hand motions was 20/16000, light perception was 20/32000 and no light perception was 20/64000. To allow for appropriate statistical analysis, logMAR Snellen Visual Acuity was calculated using the formula: -logMAR (Snellen Acuity). This means that normal vision (20/20) would correspond to a value of 0, legal blindness (20/200) would correspond to a value of 1, and no light perception (20/64000) would correspond to 3.5.
- Number of Participants With Complications During or After Surgery [ Time Frame: 5 years ]
- Number of Participants With Interventions After Surgery [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940823
|United States, Indiana|
|Eugene and Marilyn Glick Eye Institute|
|Indianapolis, Indiana, United States, 46202|
|United States, Tennessee|
|Vanderbilt Eye Institute|
|Nashville, Tennessee, United States, 37232|
|United States, Wisconsin|
|Drs. Massaro and Kalenak|
|Milwaukee, Wisconsin, United States, 53226|
|Toronto, Ontario, Canada, L5L 1W8|
|Montreal Glaucoma Institute|
|Montreal, Quebec, Canada, H1V 1G5|
|Clinic of Las Condes|
|Study Chair:||Iqbal K Ahmed, MD||University of Toronto Department of Ophthalmology & Vision Sciences|
|Study Director:||Panos G Christakis, BS||Yale School of Medicine|
|Principal Investigator:||James C Tsai, MD||Yale Ophthalmology & Visual Science|
|Principal Investigator:||Jeffrey W Kalenak, MD||Drs. Massaro & Kalenak, SC|
|Principal Investigator:||Louis B Cantor, MD||Department of Ophthalmology, Indiana University|
|Principal Investigator:||Jeffrey A Kammer, MD||Department of Ophthalmology and Visual Sciences: Vanderbilt University, School of Medicine|
|Principal Investigator:||Paul J Harasymowycz, MD||University of Montreal: Department of Ophthalmology|
|Principal Investigator:||Juan J Mura, MD||Clinic of Las Condes|