Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology 2015 Feb;122(2):308-16
Date
12/03/2014Pubmed ID
25439606Pubmed Central ID
PMC4306613DOI
10.1016/j.ophtha.2014.08.043Scopus ID
2-s2.0-84921460861 (requires institutional sign-in at Scopus site) 268 CitationsAbstract
PURPOSE: To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt 101-350 Glaucoma Implant (BGI) (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma.
DESIGN: Multicenter, randomized, controlled clinical trial.
PARTICIPANTS: A total of 276 patients, including 143 in the AGV group and 133 in the BGI group.
METHODS: Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥18 mmHg in whom glaucoma drainage implant (GDI) surgery was planned were randomized to implantation of an AGV or a BGI.
MAIN OUTCOME MEASURES: Surgical failure, IOP, visual acuity (VA), use of glaucoma medications, and complications.
RESULTS: At 5 years, IOP (mean ± standard deviation [SD]) was 14.7±4.4 mmHg in the AGV group and 12.7±4.5 mmHg in the BGI group (P = 0.015). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2±1.4 in the AGV group and 1.8±1.5 in the BGI group (P = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group (P = 0.65). The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures; P = 0.003). Eleven eyes in the AGV group (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared with 22 eyes (47% of failures) in the BGI group. Change in logarithm of the minimum angle of resolution VA (mean ± SD) at 5 years was 0.42±0.99 in the AGV group and 0.43±0.84 in the BGI group (P = 0.97).
CONCLUSIONS: Similar rates of surgical success were observed with both implants at 5 years. The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV, but the BGI was associated with twice as many failures because of safety issues.
Author List
Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM, Ahmed Baerveldt Comparison Study GroupMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Antihypertensive Agents
Female
Glaucoma
Glaucoma Drainage Implants
Humans
Intraocular Pressure
Intraoperative Complications
Male
Middle Aged
Postoperative Complications
Prosthesis Implantation
Reoperation
Tonometry, Ocular
Trabeculectomy
Treatment Failure
Treatment Outcome
Visual Acuity
