Health TrialsbyHealthPanel

Patch-free Occlusion Therapy

ConditionAmblyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorRetina Foundation of the Southwest

About this trial

The purpose of the study is to determine whether a patch-free occlusion therapy 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 the treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

3-12 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

myopia > -3.00D

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patch-free occlusion therapy

    Device

    Use of filters in glasses to provide occlusion therapy

  • Adhesive patch

    Device

    Standard-of-care occlusion therapy with an adhesive patch

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Patch-free occlusion therapyExperimental 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 measured with a logMAR visual acuity chart

change in logMAR relative to baseline

Time frame
12 weeks

Secondary outcomes

1

Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart

change in logMAR relative to baseline

Time frame
6,18, and 24 weeks
2

Adherence to patching or viewing videos with glasses measured with a sensor

cumulative hours of treatment with the patch or glasses used to watch videos objectively monitored with the skin temperature sensitive Theramon sensor

Time frame
6 and 12 weeks
3

Proportion of children who have recovered

Proportion of children who attain amblyopic eye visual acuity of 0.1 logMAR or better

Time frame
6 and 12 weeks
4

Change in extent of suppression assessed with W4 test

changes in log deg measure with W4 test

Time frame
6 and 12 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
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