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This study is designed to answer the question: What if the Intermittent Occlusion (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks?
Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled and randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or 2) Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.
Enrollment
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Inclusion criteria
The following criteria must be met for the patient to be enrolled in the study:
Age 3 to < 8 years
Unilateral amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
Criteria for strabismus: At least one of the following criteria must be met:
Criteria for anisometropia: At least one of the following criteria must be met:
Amblyopic eye has no myopia (> -0.25 D spherical equivalent).
Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
No previous amblyopia treatment within 6 months.
Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction within 6 months:
Requirements for spectacle correction:
For patients meeting criteria for only strabismus
For patients meeting criteria for anisometropia or combined-mechanism
Spectacles meeting above criteria must be worn either:
for 4 weeks immediately prior to enrollment, or
until visual acuity in amblyopic eye is stable (defined as two consecutive visual acuity measurements at least 4 weeks apart with no improvement of one line or more)
An acuity measurement done any of the following ways may be considered the first of two consecutive measurements:
Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
Ocular examination within 6 months prior to enrollment.
Gestational age > 34 weeks and birth weight > 1500 grams
Parent willing to accept randomization
Parent willing to be contacted and has access to phone
Parent does not anticipate relocation outside area within study period.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
32 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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