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Randomized Controlled Trial
. 2016 Mar:163:75-82.e3.
doi: 10.1016/j.ajo.2015.11.023. Epub 2015 Nov 18.

Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up

Collaborators, Affiliations
Randomized Controlled Trial

Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up

Donald L Budenz et al. Am J Ophthalmol. 2016 Mar.

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.

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Figures

Figure 1
Figure 1
Cumulative probability of experiencing a serious complication within five years of surgery in the Ahmed Baerveldt Comparison Study.
Figure 2
Figure 2
Cumulative probability of requiring an operation for complications within five years of surgery in the Ahmed Baerveldt Comparison Study.
Figure 3
Figure 3
Cumulative probability of phakic subjects requiring cataract extraction within five years of surgery in the Ahmed Baerveldt Comparison Study.

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