Binocular Amblyopia Treatment

ConditionAmblyopia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age4-10

SponsorRetina Foundation of the Southwest

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 4-10 y

male and female

strabismic, anisometropic, or combined mechanism amblyopia

amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR

Disqualifiers

prematurity ≥8 weeks

coexisting ocular or systemic disease

developmental delay

strabismus >5pd

Trial design

Design model

Parallel

Treatments tested in this trial

Binocular games for treatment of amblyopia
Other intervention
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

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: Standard Contrast IncrementActive comparator 1 intervention

Group B: Reduced Contrast IncrementExperimental treatment 1 intervention

Group C: No Contrast IncrementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

baseline vs 8 weeks

Secondary outcomes

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

Time frame

baseline vs 2, 4, 6, and 12 weeks

Change in stereoacuity

Randot Preschool Stereoacuity Test

Time frame

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

Change in suppression

Dichoptic Letter Chart

Time frame

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

Other outcomes

Change in accommodation

Accuracy of accommodation to a near target (Grand Seiko)

Time frame

baseline vs 8 week

Change in motion perception

Motion-defined form

Time frame

baseline vs 8 weeks

Change in fixation stability

Bivariate contour ellipse area

Time frame

baseline vs 8 weeks

Reading speed

Reading speed in wpm

Time frame

baseline vs 4 and 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Retina Foundation of the Southwest

Lead sponsor

National Eye Institute (NEI)

Collaborator

Source ClinicalTrials.gov

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