title: Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study.
abstract: OBJECTIVE
  To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens (IOL) implantation.
  
  
  METHODS
  Prospective, randomized clinical trial.
  
  
  METHODS
  The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter (n = 12) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with unilateral congenital cataract.
  
  
  METHODS
  Infants underwent cataract surgery with or without placement of an IOL.
  
  
  METHODS
  The rate, character, and severity of intraoperative complications (ICs), adverse events (AEs), and additional intraocular surgeries (AISs) during the first postoperative year in the 2 groups were analyzed.
  
  
  RESULTS
  There were more patients with ICs (28% vs. 11%; P = 0.031), AEs (77% vs. 25%; P<0.0001), and AISs (63% vs. 12%; P<0.0001) in the IOL group than the contact lens group. Iris prolapse was the most common IC. The most common AE was visual axis opacification, and the most common additional intraocular reoperation was a clearing of visual axis opacification.
  
  
  CONCLUSIONS
  The rates of ICs, AEs, and AISs 1 year after surgery were numerically higher in the IOL group, but their functional impact does not clearly favor either treatment group.
  
  
  BACKGROUND
  The author(s) have no proprietary or commercial interest in any materials discussed in this article.
authors.affiliation: Indiana University Medical Center, Indianapolis, Indiana 46202, USA. dplager@iupui.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Plager
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Lynn
authors.forename: Edward G
authors.initials: EG
authors.lastname: Buckley
authors.forename: M Edward
authors.initials: ME
authors.lastname: Wilson
authors.forename: Scott R
authors.initials: SR
authors.lastname: Lambert
mesh_terms: D001036:Aphakia, Postcataract / Q000503:physiopathology / Q000628:therapy*; D058442:Capsule Opacification / Q000209:etiology / Q000601:surgery; D002386:Cataract / Q000151:congenital*; D002387:Cataract Extraction; D003261:Contact Lenses; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007431:Intraoperative Complications; D019654:Lens Implantation, Intraocular; D011183:Postoperative Complications; D011446:Prospective Studies; D012086:Reoperation; D014792:Visual Acuity / Q000502:physiology