Amblyopia
Conditions
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.
Interventions
DEVICEIO-therapy Glasses
Sponsors
Salus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
The following criteria must be met for the patient to be enrolled in the study: 1. Age 3 to \< 8 years 2. 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 3. Amblyopic eye has no myopia (\> -0.25 D spherical equivalent). 4. 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) 5. No previous amblyopia treatment within 6 months. 6. 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. 7. Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment. 8. Ocular examination within 6 months prior to enrollment. 9. Gestational age \> 34 weeks and birth weight \> 1500 grams 10. Parent willing to accept randomization 11. Parent willing to be contacted and has access to phone 12. Parent does not anticipate relocation outside area within study period.
Exclusion criteria
1. Amblyopic eye has myopia worse than -3.00 D spherical equivalent. 2. Prior intraocular or refractive surgery 3. Ocular pathologies that impact vision 4. Cognitive impairment that prohibits accurate data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intense 12-hour IO-therapy Group Participants wear 12-hour daily IO-therapy glasses for 4 weeks
IO-therapy Glasses | 18 |
| Standard 4-hour IO-therapy Group Participants wear 4-hour daily IO-therapy glasses for 12 weeks
IO-therapy Glasses | 14 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Intense 12-hour IO-therapy Group | Standard 4-hour IO-therapy Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 14 Participants | 32 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.7 years STANDARD_DEVIATION 1.4 | 6.0 years STANDARD_DEVIATION 1.5 | 5.8 years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 8 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
| Visual acuity at baseline | 0.38 logMAR STANDARD_DEVIATION 0.11 | 0.385 logMAR STANDARD_DEVIATION 0.11 | 0.38 logMAR STANDARD_DEVIATION 0.11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 12 |
| other Total, other adverse events | 0 / 7 | 0 / 12 |
| serious Total, serious adverse events | 0 / 7 | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intense 12-hour IO-therapy Group | Visual Acuity Improvement | 0.17 logMAR | Standard Deviation 0.11 |
| Standard 4-hour IO-therapy Group | Visual Acuity Improvement | 0.13 logMAR | Standard Deviation 0.12 |
Comparison: Baseline and primary visit outcomep-value: 0.4895% CI: [-0.08, 0.16]t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intense 12-hour IO-therapy Group | Objective Adherence | 43.0 percent | Standard Deviation 12.7 |
| Standard 4-hour IO-therapy Group | Objective Adherence | 54.1 percent | Standard Deviation 40.6 |
p-value: 0.4495% CI: [-41.3, 19.3]t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intense 12-hour IO-therapy Group | Objective Total Treatment Hours | 135.5 hour | Standard Deviation 30.5 |
| Standard 4-hour IO-therapy Group | Objective Total Treatment Hours | 109.2 hour | Standard Deviation 58.7 |
p-value: 0.2695% CI: [-21.75, 74.2]t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intense 12-hour IO-therapy Group | Stereoacuity Test | 3.04 log(arcsec) | Standard Deviation 0.78 |
| Standard 4-hour IO-therapy Group | Stereoacuity Test | 3.16 log(arcsec) | Standard Deviation 0.93 |
p-value: 0.2695% CI: [-0.75, 0.99]t-test, 2 sided