Health TrialsbyHealthPanel

Improving Control of Intermittent Exotropia

ConditionIntermittent Exotropia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorRetina Foundation of the Southwest

About this trial

To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of IXT or XT at Distance & IXT or XP at near (Basic or Pseudo Divergence Excess subtype of IXT)

No surgery planned for 6 months

Disqualifiers

Prior eye muscle surgery

Prior binocular treatment or vision therapy

Amblyopia

Neurological conditions, seizure disorders, vestibular abnormalities, or frequent headache

Trial design

Design model

Parallel

Treatments tested in this trial

  • dichoptic videos

    Other intervention

    custom designed dichoptic videos

  • standard videos

    Other intervention

    standard videos

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1: Dichoptic VideosExperimental treatment 1 intervention
Group B: Group 2: Standard VideosSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in control of intermittent exotropia

change percent time alignment is present at 8 weeks vs at baseline

Time frame
8 weeks

Secondary outcomes

1

Improvement in control of intermittent exotropia

change percent time alignment is present at 4 weeks vs at baseline

Time frame
4 weeks
2

Improvement in control of intermittent exotropia

change percent time alignment is present at 12 weeks off-treatment weeks vs at baseline

Time frame
12 weeks off-treatment
3

Change in distance stereoacuity

change in Distance Randot test score at 4 weeks vs at baseline

Time frame
4 weeks
4

Change in distance stereoacuity

change in Distance Randot test score at 8 weeks vs at baseline

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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

Retina Foundation of the Southwest

Lead sponsor

Source ClinicalTrials.gov
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