Binocular iPad Sub-Study

NCT02365090 | Active Not Recruiting

• 1 other identifier: Binocular iPad Sub-Study
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine whether a binocular iPad game app is effective in improving visual acuity and reducing interocular suppression in amblyopic children
2. 2.To compare the amount of visual acuity improvement achieved with the binocular game app to the amount achieved with patching (standard treatment for amblyopia)

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 weeks (for deprivation amblyopia)

Secondary Outcomes (4)

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

  4 and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 8 weeks (for deprivation amblyopia)

• Stereoacuity Randot Preschool Stereoacuity Test

  2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 and 8 weeks (for deprivation amblyopia)

• Interocular Suppression Dichoptic Motion Coherence Threshold (<7y) & Dichoptic Letter Contrast Threshold (7+ y)

  2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4and 8 weeks (for deprivation amblyopia)

• Fixation Stability BCEA during 30 sec fixation assessed using the EyeLink system

  2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 and 8 weeks (for deprivation amblyopia)

Study Arms (2)

patching (occlusion therapy)

ACTIVE COMPARATOR

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

Other: patching

binocular games

EXPERIMENTAL

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

Other: binocular games

Interventions

patching OTHER

covering the sound eye with a patch to force use of the amblyopic eye

Also known as: occlusion therapy

patching (occlusion therapy)

binocular games OTHER

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

binocular games

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Retina Foundation of the Southwest: lead

Study Sites (1)

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Related Publications (3)

• Jost RM, Kelly KR, Birch EE. Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23.

  PMID: 37619861 DERIVED

• 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.

  PMID: 33069871 DERIVED

• 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.

  PMID: 27832248 DERIVED

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr. Research Scientist

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 18, 2015
• Study Start: February 1, 2015
• Primary Completion: December 15, 2021
• Study Completion: December 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-04

Locations

US (1)