title: A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia.
abstract: OBJECTIVE
  To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia (IXT) in children.
  
  
  METHODS
  Multicenter, randomized clinical trial.
  
  
  METHODS
  Three hundred fifty-eight children 3 to <11 years of age with previously untreated (except for refractive correction) IXT and near stereoacuity of 400 seconds of arc or better were enrolled. Intermittent exotropia met the following criteria: (1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near; (2) exodeviation (tropia or phoria) of at least 15 prism diopters (PD) at distance or near by prism and alternate cover test (PACT); and (3) exodeviation of at least 10 PD at distance by PACT.
  
  
  METHODS
  Participants were assigned randomly either to observation (no treatment for 6 months) or to patching for 3 hours daily for 5 months, with a 1-month washout period of no patching before the 6-month primary outcome examination.
  
  
  METHODS
  The primary outcome was deterioration at either the 3-month or the 6-month follow-up visit, defined as: (1) constant exotropia measuring at least 10 PD at distance and near by simultaneous prism and cover test, and/or (2) near stereoacuity decreased by at least 2 octaves from baseline, both assessed by a masked examiner and confirmed by a retest. Participants who were prescribed any nonrandomized treatment without first meeting either deterioration criteria also were counted as having deteriorated.
  
  
  RESULTS
  Of the 324 participants (91%) completing the 6-month primary outcome examination, deterioration occurred in 10 of the 165 participants (6.1%) in the observation group (3 of these 10 started treatment without meeting deterioration criteria) and in 1 of the 159 participants (0.6%) in the part-time patching group (difference, 5.4%; lower limit of 1-sided exact 95% confidence interval, 2.0%; P = 0.004, 1-sided hypothesis test).
  
  
  CONCLUSIONS
  Deterioration of previously untreated childhood IXT over a 6-month period is uncommon with or without patching treatment. Although there is a slightly lower deterioration rate with patching, both management approaches are reasonable for treating children 3 to 10 years of age with IXT.
authors.affiliation: Southern California College of Optometry, Marshall B. Ketchum University, Fullerton, California. Electronic address: pedig@jaeb.org.
authors.forename: Susan A
authors.initials: SA
authors.lastname: Cotter
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Brian G
authors.initials: BG
authors.lastname: Mohney
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Danielle L
authors.initials: DL
authors.lastname: Chandler
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Holmes
authors.affiliation: Wilmer Ophthalmological Institute, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Michael X
authors.initials: MX
authors.lastname: Repka
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Michele
authors.initials: M
authors.lastname: Melia
authors.affiliation: Duke Eye Center, Durham, North Carolina.
authors.forename: David K
authors.initials: DK
authors.lastname: Wallace
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Roy W
authors.initials: RW
authors.lastname: Beck
authors.affiliation: Retina Foundation of the Southwest, Dallas, Texas.
authors.forename: Eileen E
authors.initials: EE
authors.lastname: Birch
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Raymond T
authors.initials: RT
authors.lastname: Kraker
authors.affiliation: Bascom Palmer Eye Institute, Miami, Florida.
authors.forename: Susanna M
authors.initials: SM
authors.lastname: Tamkins
authors.affiliation: Houston Eye Associates, The Woodlands, Texas.
authors.forename: Aaron M
authors.initials: AM
authors.lastname: Miller
authors.affiliation: Pediatric Ophthalmology of Erie, Erie, Pennsylvania.
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Sala
authors.affiliation: Private Practice, Rockville, Maryland.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Glaser
mesh_terms: D001458:Bandages; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D005099:Exotropia / Q000628:therapy*; D005135:Eye Protective Devices; D005260:Female; D006801:Humans; D008297:Male; D014792:Visual Acuity