Intermittent Exotropia
Conditions
Keywords
IXT
Brief summary
To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to \< 11 years old.
Detailed description
Intermittent exotropia (IXT) is the most common form of childhood-onset exotropia with an incidence of 32.1 per 100,000 in children. Before surgery, many cases of IXT are treated using non-surgical interventions, such as part-time alternate occlusion. However, the alternating occlusion with traditional patches is usually out of control. The investigators are uncertain about the amount of alternating in patching treatment. Here, the investigators introduce controlled intermittent alternating occlusion (CIAO) therapy, which is provided by a new electronic device, -liquid crystal glasses. This study is to determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to \< 11 years old. Children with IXT will be randomized into either an observation group or a CIAO therapy group.
Interventions
DEVICECIAO therapy Amblyz glasses
3-hour CIAO Therapy Amblyz glasses
Sponsors
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Intermittent exotropia (manifest deviation) meeting all of the following criteria: * Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near * Exodeviation at least 15PD at distance OR near measured by prism and alternate cover test (PACT) * Exodeviation at least 10PD at distance measured by PACT * No previous surgical or non-surgical treatment for IXT (other than refractive correction) * Visual acuity in the worse eye 0.3 logMAR or better (20/40 on ATS HOTV or 70 letters on E-ETDRS) for children ≥ 3 years of age * No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS) for children ≥ 7 years of age * Investigator not planning to initiate amblyopia treatment * No hyperopia greater than +3.50 D spherical equivalent in either eye * No myopia greater than -6.00 D spherical equivalent in either eye * No prior strabismus, intraocular, or refractive surgery * No abnormality of the cornea, lens, or central retina * Investigator willing to observe the IXT untreated for 3 years unless specific criteria for deterioration are met.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Measure of IXT Control Score | 12 weeks; 24 weeks | IXT control score: referring to the Pediatric eye disease investigator group (PEDIG). PEDIG scale of control for IXT 1-5 is defined as the following: 5 = Constant exotropia 4 = exotropia \> 50% of the 30-sec period before dissociation 3 = exotropia \< 50% of the 30-sec period before dissociation 2 = No exotropia unless dissociated, recovers in \> 5 sec 1 = No exotropia unless dissociated, recovers in 1-5 sec 0 = No exotropia unless dissociated, recovers in \< 1 sec (phoria) Not Applicable = No exotropia present |
Other
| Measure | Time frame | Description |
|---|---|---|
| Amblyopia | 3 Months | It is defined when visual acuity between two eyes equal or over 2 logMAR lines. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CIAO Therapy Intervention with wearing 3-hour daily CIAO therapy glasses
CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses | 5 |
| Observation To observe as one kind of standard care for IXT. | 3 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
Baseline characteristics
| Characteristic | CIAO Therapy | Observation | Total |
|---|---|---|---|
| Age, Continuous | 5.7 Year STANDARD_DEVIATION 1.94 | 6.24 Year STANDARD_DEVIATION 4.17 | 5.91 Year STANDARD_DEVIATION 2.68 |
| IXT Control Score at distance | 4 units on a scale STANDARD_DEVIATION 0.71 | 2.67 units on a scale STANDARD_DEVIATION 0.57 | 3.5 units on a scale STANDARD_DEVIATION 0.92 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 0 / 5 | 0 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
Primary
Change in Composite Measure of IXT Control Score
IXT control score: referring to the Pediatric eye disease investigator group (PEDIG). PEDIG scale of control for IXT 1-5 is defined as the following: 5 = Constant exotropia 4 = exotropia \> 50% of the 30-sec period before dissociation 3 = exotropia \< 50% of the 30-sec period before dissociation 2 = No exotropia unless dissociated, recovers in \> 5 sec 1 = No exotropia unless dissociated, recovers in 1-5 sec 0 = No exotropia unless dissociated, recovers in \< 1 sec (phoria) Not Applicable = No exotropia present
Time frame: 12 weeks; 24 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Observation | Change in Composite Measure of IXT Control Score | 5 units on a scale |
Other Pre-specified
Amblyopia
It is defined when visual acuity between two eyes equal or over 2 logMAR lines.
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CIAO Therapy | Amblyopia | 0 Participants |
| Observation | Amblyopia | 0 Participants |