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NCT Number: NCT03288948

Binocular Amblyopia Treatment

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

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location status: Recruiting

Location contact

Eileen E Birch, PhD

PRINCIPAL_INVESTIGATOR

Pediatric Laboratory

CONTACT

2143633911 ext. 113

About this study

To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment.

Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA >0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 4 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

Exclusion criteria

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

Treatment and study plan

Binocular games for treatment of amblyopia

Other

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

Primary outcomes

  1. Change in visual acuity of the amblyopic eye

    Time frame: baseline vs 8 weeks

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

Secondary outcomes

  1. Change in visual acuity of the amblyopic eye

    Time frame: baseline vs 2, 4, 6, and 12 weeks

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

  2. Change in stereoacuity

    Time frame: baseline vs 2, 4, 6, 8, 12 weeks

    Randot Preschool Stereoacuity Test

  3. Change in suppression

    Time frame: baseline vs 2, 4, 6, 8, 12 weeks

    Dichoptic Letter Chart

Other outcomes

  1. Change in accommodation

    Time frame: baseline vs 8 week

    Accuracy of accommodation to a near target (Grand Seiko)

  2. Change in motion perception

    Time frame: baseline vs 8 weeks

    Motion-defined form

  3. Change in fixation stability

    Time frame: baseline vs 8 weeks

    Bivariate contour ellipse area

  4. Reading speed

    Time frame: baseline vs 4 and 8 weeks

    Reading speed in wpm

  5. Fine motor skills

    Time frame: baseline vs 4 and 8 weeks

    M-ABC

  6. Self-perception

    Time frame: baseline vs 8 weeks

    self-perception questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Krista Kelly, PhD

CONTACT

[email protected]

2143633911 ext. 113

Reed Jost, MS

CONTACT

[email protected]

2143633911 ext. 113

Sponsors and collaborators

Lead sponsor

Retina Foundation of the Southwest

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Sep 20, 2017
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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