NCT03288948

Brief Summary

To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Aug 2017Dec 2026

Study Start

First participant enrolled

August 31, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

9.3 years

First QC Date

September 18, 2017

Last Update Submit

February 19, 2026

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • Change in visual acuity of the amblyopic eye

    ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years

    baseline vs 8 weeks

Secondary Outcomes (3)

  • Change in visual acuity of the amblyopic eye

    baseline vs 2, 4, 6, and 12 weeks

  • Change in stereoacuity

    baseline vs 2, 4, 6, 8, 12 weeks

  • Change in suppression

    baseline vs 2, 4, 6, 8, 12 weeks

Other Outcomes (6)

  • Change in accommodation

    baseline vs 8 week

  • Change in motion perception

    baseline vs 8 weeks

  • Change in fixation stability

    baseline vs 8 weeks

  • +3 more other outcomes

Study Arms (3)

Standard Contrast Increment

ACTIVE COMPARATOR
Other: Binocular games for treatment of amblyopia

Reduced Contrast Increment

EXPERIMENTAL
Other: Binocular games for treatment of amblyopia

No Contrast Increment

EXPERIMENTAL
Other: Binocular games for treatment of amblyopia

Interventions

Binocular games for treatment of amblyopiaOTHER

playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye

No Contrast IncrementReduced Contrast IncrementStandard Contrast Increment

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 4-10 y
  • male and female
  • strabismic, anisometropic, or combined mechanism amblyopia
  • amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
  • fellow eye best-corrected visual acuity ≤0.1 logMAR
  • interocular visual acuity difference ≥0.3 logMAR
  • wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits
  • weeks apart.
  • child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period
  • parent's informed consent
  • child must demonstrate understanding and ability to play binocular games

You may not qualify if:

  • prematurity ≥8 weeks
  • coexisting ocular or systemic disease
  • developmental delay
  • strabismus \>5pd
  • any binocular amblyopia treatment in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

RECRUITING

Related Publications (2)

  • 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: 37619861DERIVED

  • Jost RM, Kelly KR, Hunter JS, Stager DR Jr, Luu B, Leffler JN, Dao L, Beauchamp CL, Birch EE. A randomized clinical trial of contrast increment protocols for binocular amblyopia treatment. J AAPOS. 2020 Oct;24(5):282.e1-282.e7. doi: 10.1016/j.jaapos.2020.06.009. Epub 2020 Oct 9.

    PMID: 33045374DERIVED

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Reed Jost, MS

CONTACT

2143633911reedjost@retinafoundation.org

Krista Kelly, PhD

CONTACT

2143633911kkelly@rfsw.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 20, 2017

Study Start

August 31, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

we will only share aggregated data

Locations

US(1)