Health TrialsbyHealthPanel

Video Treatment for Amblyopia

ConditionAmblyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-7
SponsorRetina Foundation of the Southwest

About this trial

The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 3-7 years

male and female

strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)

interocular visual acuity difference ≥0.3 logMAR

Disqualifiers

prematurity ≥8 wk

coexisting ocular or systemic disease

developmental delay

strabismus >5 pd

Trial design

Design model

Parallel

Treatments tested in this trial

  • Asynchronous 3D movies

    Device

    3D movies streamed at home for viewing on a handheld lenticular 3D screen

  • Patching

    Device

    Adhesive patch to cover the fellow eye

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Asynchronous moviesExperimental treatment 1 intervention
Group B: Standard-of-care patching with an adhesive patchActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in amblyopic eye visual acuity using a logMAR chart

change in amblyopic eye logMAR visual acuity relative to baseline

Time frame
6 weeks

Secondary outcomes

1

Change in amblyopic eye visual acuity using a logMAR chart

change in amblyopic eye logMAR visual acuity relative to baseline at 2, 8, and 10 weeks

Time frame
2, 8, and 10 weeks
2

Change in extent suppression assessed with the W4 test

change in log deg assessed with the W4 test relative to baseline

Time frame
6 weeks
3

Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test

change in log arcsec in stereoacuity assessed with the Randot Preschool Stereoacuity Test

Time frame
6 weeks
4

Change in motor skills assessed with the Movement Assessment Battery for Children -2

change in standard scores obtained with the Movement Assessment Battery for Children -2 (MABC-2; (normed and scaled 0-19, with 10 as an average score, 5-6 as "at risk", and \<5 as "significant impairment")

Time frame
6 weeks

Other outcomes

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
Apply now