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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Salus University
Elkins Park, Pennsylvania, United States
Visual Acuity Improvement
visual acuity difference between the primary outcome measure and baseline in the amblyopic eye; visual acuity was measured with ATS- HOTV method
Time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Stereoacuity Test
Stereoacuity in arcsec was converted to log scale. so log10(stereo) will be reported. The higher value indicates a poorer binocular visual function.
Time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Objective Total Treatment Hours
Objective total treatment hours at the primary outcome visit measured with a microsensor
Time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Objective Adherence
objective adherence measured with a microsensor to the treatment regimen
Time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group
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