Clinical trial NCT00945100: Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Official title: Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Amblyopia
Keywords: Amblyopia
patching
occlusion
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2009-07-23
Enrollment: 169
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 \>3 logMAR 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 for patients being treated with 2 hours of patching per day who are entering the study on treatment)
  * No simultaneous treatment with patching and atropine
  * No use of atropine in combination with the sound eye spectacle lens reduced by more 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 20/100 or 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 Criteria:

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

Primary outcomes:
measure: Distribution of 10-week Amblyopic Eye Visual Acuity
timeFrame: 10 weeks after randomization
measure: Mean 10-week Amblyopic Eye Visual Acuity
timeFrame: 10 weeks after randomization
measure: Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
timeFrame: Randomization to 10 weeks
measure: Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
timeFrame: Randomization to 10 weeks
Secondary outcomes:
measure: Compliance With Prescribed Patching by Treatment Group at 10 Weeks
timeFrame: 10 weeks after randomization
measure: Average Compliance With Prescribed Patching by Treatment Group
timeFrame: 10 weeks after randomization or later
measure: Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
timeFrame: 10 weeks after randomization
measure: Treatment Group Comparison of 10-week Interocular Difference
timeFrame: 10 weeks after randomization
measure: Distribution of Baseline Characteristics at the 10-week Outcome
timeFrame: 10 weeks after randomization
measure: Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
timeFrame: 10 weeks after randomization
measure: Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
timeFrame: 10 weeks after randomization
measure: Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
timeFrame: 10 weeks after randomization or later
measure: Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
timeFrame: 10 weeks after randomization or later
measure: Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
timeFrame: Randomization to 10 weeks or later
measure: Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity
timeFrame: 10 weeks after randomization or later
measure: Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit
timeFrame: 10 weeks after randomization or later
measure: Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
timeFrame: 10 weeks after randomization
measure: Mean Best Fellow Eye Visual Acuity at 10-week Outcome
timeFrame: 10 weeks after randomization
measure: Distribution of Best Fellow Eye Visual Acuity at Final Visit
timeFrame: 10 weeks after randomization or later
measure: Mean Best Fellow Eye Visual Acuity at Final Visit
timeFrame: 10 weeks after randomization or later
measure: Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
timeFrame: 10 weeks after randomization
measure: Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
timeFrame: 10 weeks after randomization
measure: Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
timeFrame: 10 weeks after randomization or later
measure: Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
timeFrame: 10 weeks after randomization or later
measure: Distribution of Randot Preschool Stereoacuity Scores at Randomization
timeFrame: Randomization
measure: Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
timeFrame: 10 weeks after randomization
measure: Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization
timeFrame: 10 weeks after randomization
measure: Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
timeFrame: Randomization
measure: Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
timeFrame: 10 weeks after randomization
measure: Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia
timeFrame: 10 weeks after randomization
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
affiliation: Duke University Eye Center
name: David K. Wallace, M.D.
role: STUDY_CHAIR
References:
citation: Wallace DK, Lazar EL, Crouch ER 3rd, Hoover DL, Kraker RT, Tamkins SM; Pediatric Eye Disease Investigator Group. Time course and predictors of amblyopia improvement with 2 hours of daily patching. JAMA Ophthalmol. 2015 May;133(5):606-9. doi: 10.1001/jamaophthalmol.2015.6. No abstract available.
citation: Pediatric Eye Disease Investigator Group; Wallace DK, Lazar EL, Holmes JM, Repka MX, Cotter SA, Chen AM, Kraker RT, Beck RW, Clarke MP, Lorenzana IJ, Petersen DB, Roberts JT, Suh DW. A randomized trial of increasing patching for amblyopia. Ophthalmology. 2013 Nov;120(11):2270-7. doi: 10.1016/j.ophtha.2013.04.008. Epub 2013 Jun 4.