Not provided
Not provided
Not provided
Not provided
no fund
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIAO Therapy | Experimental | Intervention with wearing 3-hour daily CIAO therapy glasses |
|
| Observation | No Intervention | To observe as one kind of standard care for IXT. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIAO therapy Amblyz glasses | Device | 3-hour CIAO Therapy Amblyz glasses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks; 24 weeks |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Amblyopia | It is defined when visual acuity between two eyes equal or over 2 logMAR lines. | 3 Months |
Inclusion Criteria:
Intermittent exotropia (manifest deviation) meeting all of the following criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel E Neely, MD | Glick Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glick Eye Institute, Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CIAO Therapy | Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses |
| FG001 | Observation | To observe as one kind of standard care for IXT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CIAO Therapy | Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses |
| BG001 | Observation | To observe as one kind of standard care for IXT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 weeks; 24 weeks |
|
3MO
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CIAO Therapy | Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Neely | Indiana University | 3172741214 | deneely@iupui.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| IXT Control Score at distance | 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:
| Mean | Standard Deviation | units on a scale |
|
| Observation |
To observe as one kind of standard care for IXT. |
|
|
| Other Pre-specified | Amblyopia | It is defined when visual acuity between two eyes equal or over 2 logMAR lines. | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Observation | To observe as one kind of standard care for IXT. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided