Donald L Budenz1, William J Feuer2, Keith Barton3, Joyce Schiffman2, Vital P Costa4, David G Godfrey5, Yvonne M Buys6. 1. Department of Ophthalmology, University of North Carolina, Chapel Hill, North Carolina. Electronic address: dbudenz@med.unc.edu. 2. Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine, Miami, Florida. 3. 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. 4. Department of Ophthalmology, University of Campinas, São Paulo, Brazil. 5. Glaucoma Associates of Texas, Dallas, Texas. 6. Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.
Abstract
PURPOSE: To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up. DESIGN: Multicenter, prospective randomized clinical trial. METHODS: setting: Sixteen international clinical centers. STUDY POPULATION: Two hundred seventy-six subjects aged 18-85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of >18 mm Hg. INTERVENTIONS: Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350. MAIN OUTCOME MEASURES: Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications. RESULTS:Late complications developed in 56 subjects (46.8 ± 4.8 5-year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5-year cumulative % ± SE) in the Baerveldt Glaucoma Implant group (P = .082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = .034), although this was largely driven by subjects who had tube occlusions in the 2 groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the Baerveldt Glaucoma Implant group, P = .037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = .04). CONCLUSIONS: Long-term rates of vision-threatening complications and complications resulting in reoperation were higher in the Baerveldt Glaucoma Implant than in the Ahmed Glaucoma Valve group over 5 years of follow-up.
RCT Entities:
PURPOSE: To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up. DESIGN: Multicenter, prospective randomized clinical trial. METHODS: setting: Sixteen international clinical centers. STUDY POPULATION: Two hundred seventy-six subjects aged 18-85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of >18 mm Hg. INTERVENTIONS: Ahmed Glaucoma Valve FP7 or BaerveldtGlaucoma Implant BG 101-350. MAIN OUTCOME MEASURES: Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications. RESULTS: Late complications developed in 56 subjects (46.8 ± 4.8 5-year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5-year cumulative % ± SE) in the BaerveldtGlaucoma Implant group (P = .082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and BaerveldtGlaucoma Implant groups, respectively (P = .034), although this was largely driven by subjects who had tube occlusions in the 2 groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the BaerveldtGlaucoma Implant group, P = .037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and BaerveldtGlaucoma Implant groups, respectively (P = .04). CONCLUSIONS: Long-term rates of vision-threatening complications and complications resulting in reoperation were higher in the BaerveldtGlaucoma Implant than in the Ahmed Glaucoma Valve group over 5 years of follow-up.
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