title: Feasibility of a clinical trial of vision therapy for treatment of amblyopia.
abstract: OBJECTIVE
  We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial.
  
  
  METHODS
  A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40-20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy.
  
  
  RESULTS
  Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures.
  
  
  CONCLUSIONS
  This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.
authors.affiliation: Indiana University School of Optometry, Bloomington, Indiana, USA. pedigvt@jaeb.org
authors.forename: Don W
authors.initials: DW
authors.lastname: Lyon
authors.forename: Kristine
authors.initials: K
authors.lastname: Hopkins
authors.forename: Raymond H
authors.initials: RH
authors.lastname: Chu
authors.forename: Susanna M
authors.initials: SM
authors.lastname: Tamkins
authors.forename: Susan A
authors.initials: SA
authors.lastname: Cotter
authors.forename: B Michele
authors.initials: BM
authors.lastname: Melia
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Holmes
authors.forename: Michael X
authors.initials: MX
authors.lastname: Repka
authors.forename: David T
authors.initials: DT
authors.lastname: Wheeler
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Sala
authors.forename: Janette
authors.initials: J
authors.lastname: Dumas
authors.forename: David I
authors.initials: DI
authors.lastname: Silbert
mesh_terms: D000293:Adolescent; D000550:Amblyopia / Q000503:physiopathology / Q000628:therapy*; D002648:Child; D003867:Depth Perception / Q000502:physiology*; D005139:Eyeglasses; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D012683:Sensory Deprivation; D016896:Treatment Outcome; D014792:Visual Acuity
references.citation: Vision Res. 1985;25(10):1445-57
references.pmid: 4090279
references.citation: Ophthalmology. 2001 Jan;108(1):163-71
references.pmid: 11150283
references.citation: Invest Ophthalmol Vis Sci. 1983 Jun;24(6):782-7
references.pmid: 6853106
references.citation: Optom Vis Sci. 1999 Apr;76(4):229-33
references.pmid: 10333185
references.citation: Trans Ophthalmol Soc U K. 1985;104 ( Pt 3):319-28
references.pmid: 3861010
references.citation: Am J Optom Physiol Opt. 1983 Jun;60(6):436-49
references.pmid: 6881274
references.citation: Arch Ophthalmol. 2006 Jun;124(6):844-50
references.pmid: 16769838
references.citation: Invest Ophthalmol Vis Sci. 2011 Jul 07;52(8):5043-8
references.pmid: 21642624
references.citation: Arch Ophthalmol. 2005 Apr;123(4):437-47
references.pmid: 15824215
references.citation: Br J Ophthalmol. 1981 Mar;65(3):167-76
references.pmid: 7225309
references.citation: Clin Exp Optom. 2005 Nov;88(6):365-75
references.pmid: 16329744
references.citation: Am J Ophthalmol. 2001 Dec;132(6):903-9
references.pmid: 11730656
references.citation: Optom Vis Sci. 1992 Nov;69(11):866-78
references.pmid: 1454304
references.citation: J Vis. 2003;3(5):380-405
references.pmid: 12875634
references.citation: Ophthalmology. 2004 Nov;111(11):2076-85
references.pmid: 15522375
references.citation: Arch Ophthalmol. 2003 May;121(5):603-11
references.pmid: 12742836
references.citation: Am J Optom Physiol Opt. 1987 Jun;64(6):393-404
references.pmid: 3307436
references.citation: Invest Ophthalmol Vis Sci. 1979 May;18(5):506-16
references.pmid: 437952
references.citation: Am J Ophthalmol. 1961 Aug;52:197-200
references.pmid: 13681091
references.citation: Vision Res. 2011 Sep 15;51(18):2008-20
references.pmid: 21840334
references.citation: Clin Exp Optom. 2010 Sep;93(5):287-99
references.pmid: 20533925
references.citation: Am J Ophthalmol. 2003 Feb;135(2):194-205
references.pmid: 12566024
references.citation: J Am Optom Assoc. 1981 Oct;52(10):801-6
references.pmid: 7320372
references.citation: Eye (Lond). 1991;5 ( Pt 5):576-84
references.pmid: 1794423