Amblyopia
Conditions
Keywords
amblyopia
Brief summary
Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized clinical trial reports of response to AmblyzTM glasses treatment of amblyopia. Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as traditional patching treatment. The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the standard 6-hour patching treatment. This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating amblyopia. Moderate amblyopia: Children ages 3 to \<8 years with visual acuity of 20/40 to 20/80 in the amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses treatment group and standard 2-hour patching control group. Severe amblyopia: Children ages 3 to \<8 years with visual acuity of 20/100 to 20/400 in the amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses treatment group and standard 6-hour patching control group.
Interventions
DEVICE4-hour AmblyZ glasses
4-hour AmblyZ glasses for moderate amblyopia
DEVICE12-hour AmblyZ glasses
12-hour AmblyZ glasses for severe amblyopia
DEVICE2-hour patching
2-hour patching for moderate amblyopia
DEVICE6-hour patching
6-hour patching for severe amblyopia
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Both genders and all races are eligible to this study. * Age 3 to 8 years * Amblyopia associated with strabismus, anisometropia, or both * Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive * Visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \>3 logarithm of the minimum angle of resolution (logMAR) lines * Wearing of optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
Exclusion criteria
• No amblyopia treatment before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity Change During 12 Weeks | 12 weeks | Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reverse Amblyopia | 3 Months | it is defined that the strong eye of the patient decreases two logMAR lines over 3 months. |
| Significant Ocular Deviation Increase From the Baseline | 3 Months | The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline. |
Countries
United States
Participant flow
Recruitment details
49 patients were consented; 45 entered the trial, with 27 assigned to the IO therapy group and 18 to the patching group.
Pre-assignment details
49 patients were consented; 4 patients were not qualified. 45 entered the trial, with 27 assigned to the IO therapy group and 18 to the patching group
Participants by arm
| Arm | Count |
|---|---|
| 4-hour AmblyZ Glasses 4-hour AmblyZ glasses for moderate amblyopia
4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia | 19 |
| 2-hour Eye Patching 2-hour eye patching for moderate amblyopia
2-hour patching: 2-hour patching for moderate amblyopia | 15 |
| 12-hour AmblyZ Glasses 12-hour AmblyZ glasses for severe amblyopia
12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia | 0 |
| 6-hour Eye Patching 6-hour eye patching for severe amblyopia
6-hour patching: 6-hour patching for severe amblyopia | 0 |
| Total | 34 |
Baseline characteristics
| Characteristic | 2-hour Eye Patching | 4-hour AmblyZ Glasses | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 19 Participants | 34 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 | 5.9 year old STANDARD_DEVIATION 0.9 | 5.7 year old STANDARD_DEVIATION 1.5 | 5.8 year old STANDARD_DEVIATION 1.2 |
| Region of Enrollment United States | 15 participants | 19 participants | 34 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 22 Participants |
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 / 19 | 0 / 15 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 19 | 0 / 15 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 19 | 0 / 15 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Visual Acuity Change During 12 Weeks
Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.
Time frame: 12 weeks
Population: Visual acuity change over 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-hour AmblyZ Glasses | Visual Acuity Change During 12 Weeks | .15 logMAR | Standard Deviation 0.12 |
| 2-hour Eye Patching | Visual Acuity Change During 12 Weeks | .15 logMAR | Standard Deviation 0.11 |
p-value: 0.88t-test, 1 sided
Other Pre-specified
Reverse Amblyopia
it is defined that the strong eye of the patient decreases two logMAR lines over 3 months.
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 4-hour AmblyZ Glasses | Reverse Amblyopia | 0 Participants |
| 2-hour Eye Patching | Reverse Amblyopia | 0 Participants |
| 12-hour AmblyZ Glasses | Reverse Amblyopia | 0 Participants |
| 6-hour Eye Patching | Reverse Amblyopia | 0 Participants |
Other Pre-specified
Significant Ocular Deviation Increase From the Baseline
The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline.
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 4-hour AmblyZ Glasses | Significant Ocular Deviation Increase From the Baseline | 0 Participants |
| 2-hour Eye Patching | Significant Ocular Deviation Increase From the Baseline | 0 Participants |
| 12-hour AmblyZ Glasses | Significant Ocular Deviation Increase From the Baseline | 0 Participants |
| 6-hour Eye Patching | Significant Ocular Deviation Increase From the Baseline | 0 Participants |