Amblyopia Treatment for Children Aged 8 to 12 Years
ConditionAmblyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorRetina Foundation of the Southwest
About this trial
This study is being done to assess the effect of at-home amblyopia treatment with Curesight™ for children aged 8 to 12 years. Curesight™ allows you to stream any videos on a computer screen at home but the amblyopic eye will see the entire screen clearly while part of the image will be blurred for the other eye. There is already a pivotal clinical trial showing that this treatment is effective for young children and Curesight™ has been cleared for use as an amblyopia treatment by the FDA for children as young as 4 years.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female and male children with amblyopia age 8-12 years inclusive
Amblyopic eye visual acuity ≤ 1.0 logMar (20/32-20/200)
Interocular difference in visual acuity of 0.3 logMAR or more
Anisometropia or strabismus corrected to <5 pd
Disqualifiers
Prematurity >8 weeks
Coexisting ocular or systemic disease
Developmental delay
History of light-induced epilepsy
Trial design
Design model
Single group
Treatments tested in this trial
Curesight dichoptic videos
DeviceStreamed videos are converted into 2 anaglyph channels, blue images for the amblyopic eye and red images for the fellow eye, and are presented superimposed. The stronger eye has blur imposed in the central visual area; the weaker amblyopic eye channel is not affected by the blur.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment with Curesight videosExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improvement in best-corrected visual acuity of the amblyopic eye compared with baseline best-corrected visual acuity.
Change in logMAR best-corrected visual acuity of the amblyopic eye compared with baseline best-corrected visual acuity.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov