title: A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age.
abstract: OBJECTIVE
  To determine the effectiveness of part-time patching for treating intermittent exotropia (IXT) in young children.
  
  
  METHODS
  Multicenter, randomized clinical trial.
  
  
  METHODS
  Two hundred one children 12 to 35 months of age with untreated IXT meeting the following criteria: (1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near, and (2) 15-prism diopter (Δ) or more exodeviation at distance or near by prism and alternate cover test (PACT) but at least 10 Δ exodeviation at distance by PACT.
  
  
  METHODS
  Participants were assigned randomly to either observation (no treatment for 6 months) or patching prescribed for 3 hours daily for 5 months, followed by 1 month of no patching.
  
  
  METHODS
  The primary outcome was deterioration, defined as constant exotropia measuring at least 10 Δ at distance and near or receipt of nonprotocol treatment for IXT.
  
  
  RESULTS
  Of the 177 participants (88%) completing the 6-month primary outcome examination, deterioration occurred in 4.6% (4 of 87) of the participants in the observation group and in 2.2% (2 of 90) of the participants in the patching group (difference, 2.4%; P = 0.27; 95% confidence interval, -3.8% to +9.4%). Motor deterioration occurred in 2.3% (2 of 87) of the observation group and in 2.2% (2 of 90) of the patching group (difference, 0.08%; P = 0.55; 95% confidence interval, -5.8% to +6.1%). For the observation and patching groups, respectively, 6-month mean PACT measurements were 27.9 Δ versus 24.9 Δ at distance (P = 0.02) and 19.3 Δ versus 17.0 Δ at near (P = 0.10); 6-month mean exotropia control scores were 2.8 versus 2.3 points at distance (P = 0.02) and 1.4 versus 1.1 points at near (P = 0.26).
  
  
  CONCLUSIONS
  Among children 12 to 35 months of age with previously untreated IXT, deterioration over 6 months was uncommon, with or without patching treatment. There was insufficient evidence to recommend part-time patching for the treatment of IXT in children in this age group.
authors.affiliation: Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. Electronic address: pedig@jaeb.org.
authors.forename: Brian G
authors.initials: BG
authors.lastname: Mohney
authors.affiliation: Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, California.
authors.forename: Susan A
authors.initials: SA
authors.lastname: Cotter
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Danielle L
authors.initials: DL
authors.lastname: Chandler
authors.affiliation: Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Holmes
authors.affiliation: Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, California.
authors.forename: Angela M
authors.initials: AM
authors.lastname: Chen
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Michele
authors.initials: M
authors.lastname: Melia
authors.affiliation: Vanderbilt Eye Center, Nashville, Tennessee.
authors.forename: Sean P
authors.initials: SP
authors.lastname: Donahue
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: Raymond T
authors.initials: RT
authors.lastname: Kraker
authors.affiliation: Concord Ophthalmologic Associates, Concord, Ohio.
authors.forename: Melanie L
authors.initials: ML
authors.lastname: Christian
authors.affiliation: Wolfe Clinic, West Des Moines, Iowa.
authors.forename: Donny W
authors.initials: DW
authors.lastname: Suh
mesh_terms: D001458:Bandages; D002675:Child, Preschool; D005099:Exotropia / Q000175:diagnosis / Q000503:physiopathology* / Q000628:therapy*; D005135:Eye Protective Devices; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D019370:Observation / Q000379:methods*; D011379:Prognosis