Increasing Patching for Amblyopia in Children 3 to < 8 Years Old

Phase

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

N/A

Clinical Study ID

NCT00945100

NEI-143

2U10EY011751

Ages 3-7
All Genders

Study Summary

This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria: Major Eligibility Criteria for Run-in Phase

Age 3 to < 8 years
Amblyopia associated with strabismus, anisometropia, or both
Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3logMAR lines
Amblyopia treatment within the past 6 months subject to the following stipulations:
No more than 6 weeks of any amblyopia treatment other than spectacles (except forpatients being treated with 2 hours of patching per day who are entering thestudy on treatment)
No simultaneous treatment with patching and atropine
No use of atropine in combination with the sound eye spectacle lens reduced bymore than 1.50 D
Maximum level of treatment within the past 6 months:
Patching: up to 2 hours daily
Atropine: up to once daily
Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100or worse, then spectacles and patching can be initiated simultaneously. Eligibility Criteria for Randomization:
Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines,or amblyopic eye acuity of 20/32 with 3 lines of IOD.
Reasonable compliance with prescribed treatment, defined as wearing the patch at least 10 hours per week.

Exclusion

Exclusion Criteria:

Currently using vision therapy or orthoptics
Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patientif the above visual acuity criteria are met)
Prior intraocular or refractive surgery
Known skin reaction to patch or bandage adhesives

Study Design

August 01, 2009

March 31, 2013

Study Description

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children.1 Many practitioners prescribe 2 hours daily patching as initial therapy for amblyopia. However, many children fail to achieve normal visual acuity in the amblyopic eye with this regimen. In a randomized trial conducted by PEDIG comparing patching regimens, 71 of 92 patients with moderate amblyopia (77%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of patching 2 hours daily.2 In another PEDIG randomized trial comparing patching to spectacles alone after a period of refractive adaptation, patients were treated with 2 hours daily patching and followed every 5 weeks until there was no improvement in amblyopic eye acuity. Fifty-five of 70 patients with moderate amblyopia (79%) and 14 of 14 patients with severe amblyopia (100%) had best-measured amblyopic eye visual acuity of 20/32 or worse after a median treatment period of 10 weeks.3 When improvement with initial therapy stops and amblyopia is still present, treatment options include increasing the dosage of current treatment, switching to another treatment, maintaining the same treatment and dosage for additional months, or combining treatments. Many clinicians will choose to increase the dosage of the current treatment, in part because families have become comfortable with that particular mode of treatment. However, it is unknown whether increasing occlusion dosage will improve amblyopic eye visual acuity in these patients. We are unaware of any reports of response to intensified treatment of amblyopia.

Connect with a study center

Southern California College of Optometry
Fullerton, California 92831
United States
Site Not Available
Duke University Eye Center
Durham, North Carolina 27710
United States
Site Not Available

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