Regimens of Intermittent Occlusion Therapy for Amblyopia in Children
- Conditions
- Amblyopia
- Interventions
- Device: IO-therapy Glasses
- Registration Number
- NCT02767856
- Lead Sponsor
- Salus University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
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:
- Heterotropia at distance and/or near fixation on examination (with or without spectacles)
- History of strabismus surgery
- Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
Criteria for anisometropia: At least one of the following criteria must be met:
- >0.50 D difference between eyes in spherical equivalent
- >0.50 D difference between eyes in astigmatism in any meridian
-
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:
- Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive
- Visual acuity in the sound eye 20/32 or better
- Inter-eye acuity difference ≥ 2 logMAR lines (i.e., amblyopic eye acuity at least 2 lines worse than sound eye acuity)
-
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
- Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion.
-
For patients meeting criteria for anisometropia or combined-mechanism
- Spherical equivalent must be within 0.50 D of fully correcting the anisometropia
- Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes
- Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism
- Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction
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:
- in current glasses,
- in trial frames with full correction of hypermetropia with cycloplegia, or
- in new glasses.
-
-
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.
- Amblyopic eye has myopia worse than -3.00 D spherical equivalent.
- Prior intraocular or refractive surgery
- Ocular pathologies that impact vision
- Cognitive impairment that prohibits accurate data collection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intense 12-hour IO-therapy Group IO-therapy Glasses Participants wear 12-hour daily IO-therapy glasses for 4 weeks Standard 4-hour IO-therapy Group IO-therapy Glasses Participants wear 4-hour daily IO-therapy glasses for 12 weeks
- Primary Outcome Measures
Name Time Method Visual Acuity Improvement 4 weeks for the Intense Group and 12 weeks for the Standard Group visual acuity difference between the primary outcome measure and baseline in the amblyopic eye; visual acuity was measured with ATS- HOTV method
- Secondary Outcome Measures
Name Time Method Objective Adherence 4 weeks for the Intense Group and 12 weeks for the Standard Group objective adherence measured with a microsensor to the treatment regimen
Stereoacuity Test 4 weeks for the Intense Group and 12 weeks for the Standard Group Stereoacuity in arcsec was converted to log scale. so log10(stereo) will be reported.
The higher value indicates a poorer binocular visual function.Objective Total Treatment Hours 4 weeks for the Intense Group and 12 weeks for the Standard Group Objective total treatment hours at the primary outcome visit measured with a microsensor
Trial Locations
- Locations (1)
Salus University
🇺🇸Elkins Park, Pennsylvania, United States