title: Association Between Occlusion Therapy and Optotype Visual Acuity in Children Using Data From the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial.
abstract: OBJECTIVE
  Patching has been a mainstay in treating unilateral congenital cataract. However, its efficacy has not been rigorously assessed.
  
  
  OBJECTIVE
  To examine the association between patching and visual acuity in a cohort of children treated for unilateral congenital cataract.
  
  
  METHODS
  This study was a secondary analysis of a randomized clinical trial (Infant Aphakia Treatment Study) of infants born from August 1, 2004, through December 31, 2008, who were treated with 1 of 2 treatments for unilateral congenital cataract and followed up to 5 years of age. Data analysis was performed from March 1, 2013, to March 1, 2016.
  
  
  METHODS
  Cataract extraction and randomization to receipt of an intraocular lens vs being left aphakic for the first 5 years of life.
  
  
  METHODS
  Caregivers reported patching in the previous 48 hours in quarterly semistructured telephone interviews. The mean number of hours of patching per day was calculated from surgery to the first birthday (n = 92) and between 12 and 48 months of age (n = 102). Monocular optotype acuity was assessed at 4½ years of age by a traveling examiner using the Aphakia Treatment Study HOTV protocol.
  
  
  RESULTS
  The Infant Aphakia Treatment Study enrolled 114 children; 57 were randomized to each treatment group. At 4½ years of age, optotype visual acuity was assessed in 112 children. The current analyses exclude an additional 3 children (2 who had adverse events that limited visual potential and 1 who had Stickler syndrome), leaving 109 total children analyzed (59 female [54.1%] and 92 white [84.4%]). Caregivers reported patching their children a mean (SD) of 3.73 (1.47) hours per day in the first year of life and 3.43 (2.04) hours per day thereafter. An association between reported patching and treatment was not identified (mean difference in first year, -0.29 hours per day; 95% CI, -0.90 to 0.33 hours per day; mean difference between 12 and 48 months of age, -0.40 hours per day; 95% CI, -1.20 to 0.40 hours per day). Visual acuity was associated with reported hours of patching in the first year of life (r = -0.32; 95% CI, -0.49 to -0.13) and between 12 and 48 months of age (r = -0.36; 95% CI, -0.52 to -0.18). However, patching accounted for less than 15% of the variance in logMAR acuity at 4½ years of age.
  
  
  CONCLUSIONS
  These results support the association of occlusion throughout the preschool years with improved visual acuity in infants treated for unilateral congenital cataract. However, similar visual outcomes were achieved with varying amounts of patching. These conclusions should be interpreted in the context of limitations related to generalizability from incomplete data collected in a clinical trial.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00212134.
authors.affiliation: Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Drews-Botsch
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Marianne
authors.initials: M
authors.lastname: Celano
authors.affiliation: Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.
authors.forename: George
authors.initials: G
authors.lastname: Cotsonis
authors.affiliation: currently retired.
authors.forename: E Eugenie
authors.initials: EE
authors.lastname: Hartmann
authors.affiliation: Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Scott R
authors.initials: SR
authors.lastname: Lambert
mesh_terms: D001036:Aphakia, Postcataract / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002386:Cataract / Q000151:congenital*; D002387:Cataract Extraction; D002675:Child, Preschool; D003261:Contact Lenses; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D012189:Retrospective Studies; D012683:Sensory Deprivation; D013997:Time Factors; D014792:Visual Acuity / Q000502:physiology*