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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|