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Binocular iPad Sub-Study

Primary Purpose

Amblyopia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
patching
binocular games
Sponsored by
Retina Foundation of the Southwest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 4-14 years Female and male Amblyopia with amblyopic eye visual acuity 20/40-20/125, fellow eye visual acuity 20/16-20/25, and interocular difference in visual acuity of 3 lines or more.

Anisometropic (with or without microtropia) or fully accommodative esotropia (no tropia present with glasses), or deprivation amblyopia Wearing glasses (if needed) for 8 weeks or no change in visual acuity with glasses wear for 4-6 weeks.

Must be able to demonstrate understanding and ability to play the Dig Rush game app during the enrollment visit.

Signed informed consent obtained

Exclusion Criteria:

Prematurity ≥8 weeks Coexisting ocular or systemic disease Developmental delay Poor ocular alignment (strabismus >5 prism diopters)

Sites / Locations

  • Retina Foundation of the Southwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

patching (occlusion therapy)

binocular games

Arm Description

2 hours per day patching of the sound eye (for strabismic, anisometropic, and combined mechanism amblyopia) or current patching regimen (deprivation amblyopia)

1 hour per day (5 days per week) binocular game play

Outcomes

Primary Outcome Measures

Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y
HOTV (for children <7 y) or ETDRS for children 7+y

Secondary Outcome Measures

Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y
HOTV (for children <7 y) or ETDRS for children 7+y
Stereoacuity Randot Preschool Stereoacuity Test
Randot Preschool Stereoacuity Test
Interocular Suppression Dichoptic Motion Coherence Threshold (<7y) & Dichoptic Letter Contrast Threshold (7+ y)
Dichoptic Motion Coherence Threshold (<7y) & Dichoptic Letter Contrast Threshold (7+ y)
Fixation Stability BCEA during 30 sec fixation assessed using the EyeLink system
BCEA during 30 sec fixation assessed using the EyeLink system

Full Information

First Posted
February 10, 2015
Last Updated
June 13, 2023
Sponsor
Retina Foundation of the Southwest
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1. Study Identification

Unique Protocol Identification Number
NCT02365090
Brief Title
Binocular iPad Sub-Study
Official Title
Binocular iPad Sub-Study; Suppression in Amblyopia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Retina Foundation of the Southwest

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine whether a binocular iPad game app is effective in improving visual acuity and reducing interocular suppression in amblyopic children To compare the amount of visual acuity improvement achieved with the binocular game app to the amount achieved with patching (standard treatment for amblyopia)
Detailed Description
Although patching treatment results in improved visual acuity for most amblyopic children, some fail to achieve normal visual acuity after months or years of treatment. Even among children who do achieve normal visual acuity with amblyopia treatment, the risk for recurrence of amblyopia is high. Patching treatment is based on the premise that amblyopia is a monocular disorder that can be treated by forcing use of the amblyopic eye. However, recent studies have elucidated a clear link between binocular dysfunction and the complex constellation of deficits that characterizes amblyopia, including visual acuity, vernier acuity, fixation instability, fusional suppression, and risk for residual and recurrent amblyopia. The association of binocular dysfunction and the myriad of monocular and binocular deficits in amblyopia has led us to hypothesize that amblyopia is a monocular consequence of a primary binocular obstacle to normal visual development. Although binocular interaction does not normally occur in amblyopia, weak, noisy signals from the amblyopic eye can contribute to binocular vision if suppression by the fellow eye is reduced by signal attenuation, such as reduced stimulus contrast. In small cohorts of amblyopic adults and schoolchildren, repeated practice with a binocular Falling Blocks iPod game with reduced fellow eye contrast yielded modest visual acuity improvement after just 1-5 weeks (Hess et al 2010, 2012, 2014; Knox et al 2011; Li et al 2012). Recently, we showed that the same binocular game app approach(reduced fellow eye contrast) could be adapted for home use by amblyopic children on a larger iPad display (Li et al 2014; Birch et al 2014). These games also were effective in improving visual acuity, and the visual acuity gains were maintained for at least 6 months (Li et al 2014a, 2014b). The major limitation of both sets of studies was that the games were not very interesting and quickly became tedious to play day after day. To overcome this limitation, we propose to evaluate a new, more engaging binocular iPad adventure game to determine whether practice with a binocular iPad games app, with reduced fellow eye contrast, can improve visual acuity and reduce interocular suppression in children with amblyopia.One group of participants will include 56 children with anisometropic, strabismic, or combined mechanism amblyopia, age 4-10 years. The participants will be randomly assigned to patch 2 hours daily patching (standard-of-care treatment) or to play the iPad game app 1 hour per day 5 days per week for 2 weeks. Half of the children will have had no prior treatment for amblyopia and the other half will have had prior amblyopia treatment; these two subgroups will be randomized separately. A blocked randomization order will be provided in sealed envelopes by our consultant statistician. A second group of participants will include 40 children with deprivation amblyopia due to cataract. The participants will be randomly assigned to continue their patching regimen (if any) or to continue their current patching regimen and also play the iPad game app 1 hour per day 5 days per week for 4 weeks. iPads with the game app are loaned to the family for the duration of the study, Vision will be tested at baseline and at 2 weeks for the primary outcome of change in visual acuity (for strabismic, anisometropic, and combined mechanism amblyopia) or at baseline and 4 weeks (for deprivation amblyopia). At the primary outcome visit, the patching group will be crossed over to play the iPad game app 1 hour per day 5 days per week and return for a secondary outcome at 4 weeks (for strabismic, anisometropic, and combined mechanism amblyopia) or 8 weeks (for deprivation amblyopia). Families will have the option to discontinue or to continue with the game app for up to 8 weeks, with testing every 4 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patching (occlusion therapy)
Arm Type
Active Comparator
Arm Description
2 hours per day patching of the sound eye (for strabismic, anisometropic, and combined mechanism amblyopia) or current patching regimen (deprivation amblyopia)
Arm Title
binocular games
Arm Type
Experimental
Arm Description
1 hour per day (5 days per week) binocular game play
Intervention Type
Other
Intervention Name(s)
patching
Other Intervention Name(s)
occlusion therapy
Intervention Description
covering the sound eye with a patch to force use of the amblyopic eye
Intervention Type
Other
Intervention Name(s)
binocular games
Intervention Description
playing iPad games 1 hour per day 5 days per week to allow the child to use the amblyopic eye and the sound eye together
Primary Outcome Measure Information:
Title
Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y
Description
HOTV (for children <7 y) or ETDRS for children 7+y
Time Frame
2 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 weeks (for deprivation amblyopia)
Secondary Outcome Measure Information:
Title
Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y
Description
HOTV (for children <7 y) or ETDRS for children 7+y
Time Frame
4 and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 8 weeks (for deprivation amblyopia)
Title
Stereoacuity Randot Preschool Stereoacuity Test
Description
Randot Preschool Stereoacuity Test
Time Frame
2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 and 8 weeks (for deprivation amblyopia)
Title
Interocular Suppression Dichoptic Motion Coherence Threshold (<7y) & Dichoptic Letter Contrast Threshold (7+ y)
Description
Dichoptic Motion Coherence Threshold (<7y) & Dichoptic Letter Contrast Threshold (7+ y)
Time Frame
2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4and 8 weeks (for deprivation amblyopia)
Title
Fixation Stability BCEA during 30 sec fixation assessed using the EyeLink system
Description
BCEA during 30 sec fixation assessed using the EyeLink system
Time Frame
2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 and 8 weeks (for deprivation amblyopia)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 4-14 years Female and male Amblyopia with amblyopic eye visual acuity 20/40-20/125, fellow eye visual acuity 20/16-20/25, and interocular difference in visual acuity of 3 lines or more. Anisometropic (with or without microtropia) or fully accommodative esotropia (no tropia present with glasses), or deprivation amblyopia Wearing glasses (if needed) for 8 weeks or no change in visual acuity with glasses wear for 4-6 weeks. Must be able to demonstrate understanding and ability to play the Dig Rush game app during the enrollment visit. Signed informed consent obtained Exclusion Criteria: Prematurity ≥8 weeks Coexisting ocular or systemic disease Developmental delay Poor ocular alignment (strabismus >5 prism diopters)
Facility Information:
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33069871
Citation
Birch EE, Jost RM, Wang SX, Kelly KR. A pilot randomized trial of contrast-rebalanced binocular treatment for deprivation amblyopia. J AAPOS. 2020 Dec;24(6):344.e1-344.e5. doi: 10.1016/j.jaapos.2020.07.009. Epub 2020 Oct 16.
Results Reference
derived
PubMed Identifier
27832248
Citation
Kelly KR, Jost RM, Dao L, Beauchamp CL, Leffler JN, Birch EE. Binocular iPad Game vs Patching for Treatment of Amblyopia in Children: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1402-1408. doi: 10.1001/jamaophthalmol.2016.4224.
Results Reference
derived

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Binocular iPad Sub-Study

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