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Increasing Patching for Amblyopia in Children 3 to < 8 Years Old (ATS15)

Primary Purpose

Amblyopia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Eye Patch
Eye Patch
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia, patching, occlusion

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern California College of Optometry
  • Duke University Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control

Intensified treatment

Arm Description

2 hours daily patching

42 hours per week of patching (averaging 6 hours daily)

Outcomes

Primary Outcome Measures

Distribution of 10-week Amblyopic Eye Visual Acuity
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Mean 10-week Amblyopic Eye Visual Acuity
The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.

Secondary Outcome Measures

Compliance With Prescribed Patching by Treatment Group at 10 Weeks
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.
Average Compliance With Prescribed Patching by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Treatment Group Comparison of 10-week Interocular Difference
The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Distribution of Baseline Characteristics at the 10-week Outcome
The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis.
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)
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
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained.
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
Mean Best Fellow Eye Visual Acuity at 10-week Outcome
Distribution of Best Fellow Eye Visual Acuity at Final Visit
Mean Best Fellow Eye Visual Acuity at Final Visit
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
Distribution of Randot Preschool Stereoacuity Scores at Randomization
The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of >800. We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing. The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank.
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia

Full Information

First Posted
July 21, 2009
Last Updated
July 12, 2016
Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00945100
Brief Title
Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Acronym
ATS15
Official Title
Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
Amblyopia, patching, occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
2 hours daily patching
Arm Title
Intensified treatment
Arm Type
Active Comparator
Arm Description
42 hours per week of patching (averaging 6 hours daily)
Intervention Type
Device
Intervention Name(s)
Eye Patch
Other Intervention Name(s)
Coverlet, 3M Opticlude, Ortopad
Intervention Description
42 hours patching per week (averaging 6 hours patching daily)
Intervention Type
Device
Intervention Name(s)
Eye Patch
Other Intervention Name(s)
Coverlet, 3M Opticlude, Ortopad
Intervention Description
2 hours patching daily
Primary Outcome Measure Information:
Title
Distribution of 10-week Amblyopic Eye Visual Acuity
Description
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Time Frame
10 weeks after randomization
Title
Mean 10-week Amblyopic Eye Visual Acuity
Description
The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Time Frame
10 weeks after randomization
Title
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
Description
The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Time Frame
Randomization to 10 weeks
Title
Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
Description
The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Time Frame
Randomization to 10 weeks
Secondary Outcome Measure Information:
Title
Compliance With Prescribed Patching by Treatment Group at 10 Weeks
Description
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.
Time Frame
10 weeks after randomization
Title
Average Compliance With Prescribed Patching by Treatment Group
Description
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.
Time Frame
10 weeks after randomization or later
Title
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
Description
The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Time Frame
10 weeks after randomization
Title
Treatment Group Comparison of 10-week Interocular Difference
Description
The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Time Frame
10 weeks after randomization
Title
Distribution of Baseline Characteristics at the 10-week Outcome
Description
The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis.
Time Frame
10 weeks after randomization
Title
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Description
Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Time Frame
10 weeks after randomization
Title
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Description
A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Time Frame
10 weeks after randomization
Title
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
Description
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Time Frame
10 weeks after randomization or later
Title
Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
Description
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.
Time Frame
10 weeks after randomization or later
Title
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
Description
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Time Frame
Randomization to 10 weeks or later
Title
Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity
Description
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)
Time Frame
10 weeks after randomization or later
Title
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
Description
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained.
Time Frame
10 weeks after randomization or later
Title
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
Time Frame
10 weeks after randomization
Title
Mean Best Fellow Eye Visual Acuity at 10-week Outcome
Time Frame
10 weeks after randomization
Title
Distribution of Best Fellow Eye Visual Acuity at Final Visit
Time Frame
10 weeks after randomization or later
Title
Mean Best Fellow Eye Visual Acuity at Final Visit
Time Frame
10 weeks after randomization or later
Title
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
Time Frame
10 weeks after randomization
Title
Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
Time Frame
10 weeks after randomization
Title
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
Time Frame
10 weeks after randomization or later
Title
Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
Time Frame
10 weeks after randomization or later
Title
Distribution of Randot Preschool Stereoacuity Scores at Randomization
Description
The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of >800. We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing. The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank.
Time Frame
Randomization
Title
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
Time Frame
10 weeks after randomization
Title
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization
Time Frame
10 weeks after randomization
Title
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
Time Frame
Randomization
Title
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
Time Frame
10 weeks after randomization
Title
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia
Time Frame
10 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David K. Wallace, M.D.
Organizational Affiliation
Duke University Eye Center
Official's Role
Study Chair
Facility Information:
Facility Name
Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website at http://pedig.jaeb.org/Studies.aspx?RecID=29
Citations:
PubMed Identifier
25695355
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.
Results Reference
background
PubMed Identifier
23755872
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.
Results Reference
result

Learn more about this trial

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

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