title: Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years.
abstract: OBJECTIVE
  The efficacy and safety of primary intraocular lens (IOL) implantation during early infancy is unknown.
  
  
  OBJECTIVE
  To compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy.
  
  
  METHODS
  The Infant Aphakia Treatment Study is a randomized clinical trial with 5 years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites. A traveling examiner assessed visual acuity at age 4.5 years.
  
  
  METHODS
  Cataract surgery with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Treatment was determined through random assignment.
  
  
  METHODS
  HOTV optotype visual acuity at 4.5 years of age.
  
  
  RESULTS
  The median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups (both, 0.90 [20/159]; P = .54). About 50% of treated eyes in both groups had visual acuity less than or equal to 20/200. Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery (contact lens, 56%; IOL, 81%; P = .02). The most common adverse events in the IOL group were lens reproliferation into the visual axis, pupillary membranes, and corectopia. Glaucoma/glaucoma suspect occurred in 35% of treated eyes in the contact lens group vs 28% of eyes in the IOL group (P = .55). Since the initial cataract surgery, significantly more patients in the IOL group have had at least 1 additional intraocular surgery (contact lens, 21%; IOL, 72%; P < .001).
  
  
  CONCLUSIONS
  There was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic. However, there were significantly more adverse events and additional intraoperative procedures in the IOL group. When operating on an infant younger than 7 months of age with a unilateral cataract, we recommend leaving the eye aphakic and focusing the eye with a contact lens. Primary IOL implantation should be reserved for those infants where, in the opinion of the surgeon, the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00212134
authors.forename: Scott R
authors.initials: SR
authors.lastname: Lambert
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Lynn
authors.forename: E Eugenie
authors.initials: EE
authors.lastname: Hartmann
authors.forename: Lindreth
authors.initials: L
authors.lastname: DuBois
authors.forename: Carolyn
authors.initials: C
authors.lastname: Drews-Botsch
authors.forename: Sharon F
authors.initials: SF
authors.lastname: Freedman
authors.forename: David A
authors.initials: DA
authors.lastname: Plager
authors.forename: Edward G
authors.initials: EG
authors.lastname: Buckley
authors.forename: M Edward
authors.initials: ME
authors.lastname: Wilson
mesh_terms: D000367:Age Factors; D001035:Aphakia / Q000151:congenital* / Q000175:diagnosis / Q000601:surgery; D002386:Cataract / Q000151:congenital; D002387:Cataract Extraction / Q000379:methods; D002675:Child, Preschool; D003261:Contact Lenses / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D019654:Lens Implantation, Intraocular / Q000009:adverse effects / Q000379:methods*; D007910:Lenses, Intraocular; D008297:Male; D011182:Postoperative Care / Q000379:methods; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology*