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

Am J Ophthalmol. 2016 Mar:163:75-82.e3. doi: 10.1016/j.ajo.2015.11.023. Epub 2015 Nov 18.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Female
  • Follow-Up Studies
  • Glaucoma Drainage Implants / adverse effects*
  • Glaucoma, Open-Angle / physiopathology
  • Glaucoma, Open-Angle / surgery*
  • Humans
  • Intraocular Pressure / physiology
  • Male
  • Middle Aged
  • Postoperative Complications*
  • Prospective Studies
  • Prosthesis Implantation
  • Reoperation
  • Time Factors
  • Tonometry, Ocular
  • Visual Acuity