TY - JOUR
T1 - The Ahmed Versus Baerveldt study
T2 - One-year treatment outcomes
AU - Christakis, Panos G.
AU - Kalenak, Jeffrey W.
AU - Zurakowski, David
AU - Tsai, James C.
AU - Kammer, Jeffrey A.
AU - Harasymowycz, Paul J.
AU - Ahmed, Iqbal I.K.
N1 - Funding Information:
Author disclosures are as follows: Paul J. Harasymowycz: Abbott Medical Optics, Inc., Allergan, Inc., Pfizer, Inc., Merck and Co., Inc., and Alcon (consultant and lecturer). Iqbal I. Ahmed: Alcon (consultant, speakers honoraria, financial support); Advanced Medical Optics, Inc. (consultant, speakers honoraria); Allergan (speakers honoraria, financial support); Aquesys (consultant, financial support); Carl Zeiss Meditec (consultant, speakers honoraria, financial support); Clarity Medical Systems (consultant, speakers honoraria); Ivantis and Eyelight (consultant); iScience (consultant, speakers honoraria, financial support); Glaukos and Mastel (consultant); Merck Frosst (consultant, speakers honoraria, financial support); Microsurgical Technology (consultant, speakers honoraria); New World Medical (speakers honoraria); Oculus (consultant, speakers honoraria); Optonol (financial support); Pfizer (consultant, speakers honoraria, financial support); SOLX (consultant, speakers honoraria, financial support); STAAR (speakers honoraria); Transcend Medical (consultant); Visiogen (financial support).
Funding Information:
Financial Support: The AVB Study is supported by a research grant from the Glaucoma Research Society of Canada , Toronto, Canada (IIA, PGC) and a departmental challenge grant from Research to Prevent Blindness, Inc. , New York, NY (JCT). Our research funding sponsors had no role in the design or conduct of the study.
PY - 2011/11
Y1 - 2011/11
N2 - Objective: To report the 1-year treatment outcomes of the Ahmed Versus Baerveldt (AVB) Study. Design: Multicenter randomized clinical trial. Participants: A total of 238 patients were enrolled in the study, including 124 in the Ahmed group and 114 in the Baerveldt group. Methods: Patients aged 18 years or older with uncontrolled glaucoma refractory to medicinal, laser, and surgical therapy were randomized to undergo implantation of an Ahmed-FP7 valve (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA), to be followed for 5 years. Main Outcome Measures: The primary outcome measure was failure, defined as intraocular pressure (IOP) out of target range (518 mmHg with <20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, additional glaucoma procedures, or loss of light perception. Secondary outcome measures included IOP, medication use, visual acuity, complications, and interventions. Results: There were no significant differences in baseline ocular or demographic characteristics between the study groups with the exception of sex. Preoperatively, the study group had a mean IOP of 31.4±10.8 mmHg on a mean of 3.1±1.0 glaucoma medications with a median Snellen acuity of 20/100. The cumulative probability of failure a 1-year was 43% in the Ahmed group and 28% in the Baerveldt group (P=0.02). The mean IOP at 1 year was 16.5±5.3 mmHg in the Ahmed group and 13.6±4.8 mmHg in the Baerveldt group (P < 0.001). The mean number of glaucoma medications required was 1.6±1.3 in the Ahmed group and 1.2±1.3 in the Baerveldt group (P=0.03). Visual acuity was similar in both groups at all visits in the first year (P=0.66). In the first year after surgery, there were a similar number of patients who experienced postoperative complications in the 2 groups (45% Ahmed, 54% Baerveldt, P=0.19), but a greater number of patients in the Baerveldt group required interventions (26% Ahmed vs. 42% Baerveldt, P=0.009). Conclusions: The Baerveldt-350 group had a higher success rate than the Ahmed-FP7 group after 1 year of follow-up, but required a greater number of interventions. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
AB - Objective: To report the 1-year treatment outcomes of the Ahmed Versus Baerveldt (AVB) Study. Design: Multicenter randomized clinical trial. Participants: A total of 238 patients were enrolled in the study, including 124 in the Ahmed group and 114 in the Baerveldt group. Methods: Patients aged 18 years or older with uncontrolled glaucoma refractory to medicinal, laser, and surgical therapy were randomized to undergo implantation of an Ahmed-FP7 valve (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA), to be followed for 5 years. Main Outcome Measures: The primary outcome measure was failure, defined as intraocular pressure (IOP) out of target range (518 mmHg with <20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, additional glaucoma procedures, or loss of light perception. Secondary outcome measures included IOP, medication use, visual acuity, complications, and interventions. Results: There were no significant differences in baseline ocular or demographic characteristics between the study groups with the exception of sex. Preoperatively, the study group had a mean IOP of 31.4±10.8 mmHg on a mean of 3.1±1.0 glaucoma medications with a median Snellen acuity of 20/100. The cumulative probability of failure a 1-year was 43% in the Ahmed group and 28% in the Baerveldt group (P=0.02). The mean IOP at 1 year was 16.5±5.3 mmHg in the Ahmed group and 13.6±4.8 mmHg in the Baerveldt group (P < 0.001). The mean number of glaucoma medications required was 1.6±1.3 in the Ahmed group and 1.2±1.3 in the Baerveldt group (P=0.03). Visual acuity was similar in both groups at all visits in the first year (P=0.66). In the first year after surgery, there were a similar number of patients who experienced postoperative complications in the 2 groups (45% Ahmed, 54% Baerveldt, P=0.19), but a greater number of patients in the Baerveldt group required interventions (26% Ahmed vs. 42% Baerveldt, P=0.009). Conclusions: The Baerveldt-350 group had a higher success rate than the Ahmed-FP7 group after 1 year of follow-up, but required a greater number of interventions. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
UR - http://www.scopus.com/inward/record.url?scp=80255136254&partnerID=8YFLogxK
U2 - 10.1016/j.ophtha.2011.05.004
DO - 10.1016/j.ophtha.2011.05.004
M3 - Article
C2 - 21889801
AN - SCOPUS:80255136254
SN - 0161-6420
VL - 118
SP - 2180
EP - 2189
JO - Ophthalmology
JF - Ophthalmology
IS - 11
ER -