Clinical trial NCT00315198: Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
Official title: A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Amblyopia
Keywords: amblyopia
patching
visual activities
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2006-04-18
Enrollment: 425
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to \<7 years old.

Detailed description: The value of "near visual activities" while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patch over the sound eye, while other pediatric eye care providers do not prescribe any specific visual tasks to be performed while the patch is worn.

In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye Disease Investigator Group, near visual activities were incorporated into the prescribed treatment regimes. Although different doses of patching, combined with near visual activities, were successful in improving visual acuity in most children, it is unclear whether concurrent near visual activities enhanced the effect of patching.

This study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimens for the 17 week treatment period are: 1) 2 hours of daily patching combined with near visual activities while patching and 2)2 hours of daily patching combined with distance visual activities while patching.

Eligibility criteria: Inclusion Criteria:

* Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both.
* Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
* Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

Exclusion Criteria:

* Prior amblyopia treatment other than spectacles in the past month.
* More than one month of amblyopia treatment in the past 6 months.

Primary outcomes:
measure: Visual acuity
timeFrame: 8 weeks
Secondary outcomes:
measure: Visual acuity
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Optometry
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic Department of Ophthalmology
state: Minnesota
Study officials:
affiliation: Indiana University
name: Don Lyon, O.D.
role: STUDY_CHAIR
affiliation: Mayo Clinic Department of Ophthalmology
name: Jonathan M. Holmes, M.D.
role: STUDY_CHAIR
References:
citation: Pediatric Eye Disease Investigator Group. A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years. Ophthalmology. 2008 Nov;115(11):2071-8. doi: 10.1016/j.ophtha.2008.06.031. Epub 2008 Sep 11.
citation: Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.
citation: Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.