Three-year treatment outcomes in the Ahmed Baerveldt comparison study.
OBJECTIVE
To compare 3-year outcomes and complications of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt Glaucoma Implant (BGI) 101-350 (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma.


METHODS
Multicenter, randomized, controlled clinical trial.


METHODS
A total of 276 patients: 143 in the AGV group and 133 in the BGI group.


METHODS
Patients aged 18 to 85 years with refractory glaucoma and intraocular pressures (IOPs) ≥ 18 mmHg in whom an aqueous shunt was planned were randomized to an AGV or a BGI.


METHODS
The IOP, visual acuity (VA), supplemental medical therapy, complications, and failure (IOP >21 mmHg or not reduced by 20% from baseline, IOP <5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision).


RESULTS
At 3 years, IOP (mean ± standard deviation) was 14.3 ± ± 4.7 mmHg (AGV group) and 13.1 ± 4.5 mmHg (BGI group) (P = 0.086) on 2.0 ± 1.4 and 1.5 ± 1.4 glaucoma medications, respectively (P = 0.020). The cumulative probabilities of failure were 31.3% (standard error [SE], 4.0%) (AGV) and 32.3% (4.2%) (BGI) (P = 0.99). Postoperative complications associated with reoperation or vision loss of >2 Snellen lines occurred in 24 patients (22%) (AGV) and 38 patients (36%) (BGI) (P = 0.035). The mean change in the logarithm of the minimum angle of resolution VA at 3 years was similar (AGV: 0.21 ± 0.88, BGI: 0.26 ± 0.74) in the 2 treatment groups at 3 years (P = 0.66). The cumulative proportion of patients (SE) undergoing reoperation for glaucoma before the 3-year postoperative time point was 14.5% (3.0%) in the AGV group compared with 7.6% (2.4%) in the BGI group (P = 0.053, log rank). The relative risk of reoperation for glaucoma in the AGV group was 2.1 times that of the BGI group (95% confidence interval, 1.0-4.8; P = 0.045, Cox proportional hazards regression).


CONCLUSIONS
Implantation of the AGV was associated with the need for significantly greater adjunctive medication to achieve equal success relative to implantation of the BGI and resulted in a greater relative risk of reoperation for glaucoma. More subjects experienced serious postoperative complications in the BGI group than in the AGV group.
NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital, London, United Kingdom; Division of Epidemiology and Genetics, Institute of Ophthalmology, University College London, London, United Kingdom.
Keith
K
Barton
Department of Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, Florida.
William J
WJ
Feuer
Department of Ophthalmology, University of North Carolina, Chapel Hill, North Carolina. Electronic address: dbudenz@med.unc.edu.
Donald L
DL
Budenz
Department of Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, Florida.
Joyce
J
Schiffman
Department of Ophthalmology, University of Campinas, São Paulo, Brazil.
Vital P
VP
Costa
Glaucoma Associates of Texas, Dallas, Texas.
David G
DG
Godfrey
Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.
Yvonne M
YM
Buys
D000293:Adolescent; D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D005901:Glaucoma / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D020327:Glaucoma Drainage Implants; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology*; D007431:Intraoperative Complications; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D016016:Proportional Hazards Models; D019919:Prosthesis Implantation; D012086:Reoperation; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D000959:Antihypertensive Agents