Amblyopia
Conditions
Brief summary
This study is designed to evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia. Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group. The study also observe the effectiveness of IO-therapy glasses on two types of difficult amblyopia: deprivation amblyopia associated with congenital or developmental cataract, and myopic anisometropic amblyopia.
Detailed description
Children ages 3 to \< 8 years with severe/dense amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group. Children ages 3 to \< 8 years with deprivation amblyopia associated with congenital or developmental cataracts (visual acuity of 20/40 to 20/400 in the amblyopic eye) will be enrolled. Children ages 3 to \< 8 years with myopic anisometropic amblyopia will be enrolled into an intermittent occlusion therapy glasses (AmblyzTM) group. According to visual acuity, they will receive one of two IO-therapy glasses treatment regimens: 1) If the amblyopic eye is between 20/40 to 20/80 inclusive, 4-hour IO-therapy glasses or 2) If the amblyopic eye is between 20/100 to 20/400 inclusive, the child will receive12-hour IO-therapy glasses.
Interventions
DEVICEIO-therapy Glasses
12-hour of 50% intermittent occlusion therapy on the fellow eye.
DEVICEpatch
6-hour of eye patch on the fellow eye
Sponsors
Indiana University
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
No
Inclusion criteria
1. Age 3 to \< 8 years 2. Amblyopia associated with strabismus, anisometropia, or both 3. 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 20/100 and 20/400 inclusive * Visual acuity in the sound eye 20/32 or better 4. 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 i. 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 i. Spherical equivalent must be within 0.50 D of fully correcting the anisometropia ii. Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes iii. Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism iv. Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction 5. Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment. 6. Gestational age \> 34 weeks and birth weight \> 1500 grams 7. Parent willing to accept randomization 8. Parent willing to be contacted and has access to phone 9. Parent does not anticipate relocation outside area of active study site
Exclusion criteria
* • Amblyopic eye has myopia worse than -3.00D spherical equivalent. * Previous amblyopia treatment within 6 months. * Prior intraocular or refractive surgery * Known skin reactions to patch or bandage adhesives * Systemic diseases that may cause reduced vision such as Down syndrome. If patients are in the deprivation amblyopia category, the following criteria must be met for the patient to be enrolled in the study: 1. Age 3 to \< 8 years 2. Amblyopia due to previous congenital or developmental cataract surgery. 3. Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows: a. Visual acuity in the amblyopic eye between 20/40 and 20/400 inclusive b. Visual acuity in the sound eye 20/32 or better c. Inter-eye acuity difference ≥ 2 logMAR lines (i.e., amblyopic eye acuity at least 3 lines worse than sound eye acuity) d) Gestational age \> 34 weeks and birth weight \> 1500 grams e) Parent willing to be contacted and has access to phone. If patients are enrolled in the myopic anisometropia amblyopia category, the following criteria must be met for the patients to be enrolled in the study. * Aged 3 to \<8 years * Best-corrected VA in the amblyopic eye of 20/40 to 20/400 inclusive * Best-corrected VA in the fellow eye of 20/40 or better * Magnitude of myopic anisometropia of \> 3.00 D * Intereye acuity difference of \> 3 logMAR lines * Amblyopia associated with myopic anisometropia * Has been wearing optimal spectacle correction for a minimum of four weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity Improvement | 12± 1 weeks after treatment | Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 12-hour IO-therapy Glasses wear IO-therapy glasses for 12-hour
IO-therapy Glasses: 12-hour of 50% intermittent occlusion therapy on the fellow eye. | 2 |
| 6-hour Patching wear the eye patch for 6-hour
patch: 6-hour of eye patch on the fellow eye | 4 |
| Deprivation Amblyopia wear IO-therapy glasses depends on the severity of amblyopia. If severe, wear 12 hours; if moderate, wear 4 hours. | 2 |
| Myopic Anisometropic Amblyopia wear IO-therapy glasses depends on the severity of amblyopia. If severe, wear 12 hours; if moderate, wear 4 hours. | 3 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 0 | 0 |
| Overall Study | the device is too small for the patient. | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 12-hour IO-therapy Glasses | Total | Myopic Anisometropic Amblyopia | Deprivation Amblyopia | 6-hour Patching |
|---|---|---|---|---|---|
| Age, Continuous | 4.7 Year STANDARD_DEVIATION 0.2 | 5.7 Year STANDARD_DEVIATION 1.1 | 5.9 Year STANDARD_DEVIATION 0.6 | 6.8 Year STANDARD_DEVIATION 0.1 | 5.4 Year STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 9 Participants | 3 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 8 Participants | 0 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 2 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 1 Participants | 1 Participants | 2 Participants |
| visual acuity of amblyopic eye | 1.10 logMAR STANDARD_DEVIATION 0.28 | 0.71 logMAR STANDARD_DEVIATION 0.29 | 0.5 logMAR STANDARD_DEVIATION 0.17 | 0.75 logMAR STANDARD_DEVIATION 0.35 | 0.86 logMAR STANDARD_DEVIATION 0.17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 3 |
Outcome results
Primary
Visual Acuity Improvement
Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.
Time frame: 12± 1 weeks after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12-hour IO-therapy Glasses | Visual Acuity Improvement | 0.05 logMAR | Standard Deviation 0.07 |
| 6-hour Patching | Visual Acuity Improvement | 0.17 logMAR | Standard Deviation 0.23 |
| Deprivation Amblyopia | Visual Acuity Improvement | 0.05 logMAR | Standard Deviation 0.07 |
| Myopic Anisometropic Amblyopia | Visual Acuity Improvement | 0.1 logMAR | Standard Deviation 0.26 |