An interventional study of CIAO therapy Amblyz glasses in Intermittent Exotropia, sponsored by Indiana University School of Medicine. Terminated at 1 site in United States. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2017-11-30.
Sponsored by Indiana University School of Medicine · Not applicable, Interventional, and Treatment
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.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
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Intermittent exotropia (manifest deviation) meeting all of the following criteria:
Exclusion Criteria:
Intervention with wearing 3-hour daily CIAO therapy glasses
Device: CIAO therapy Amblyz glasses
To observe as one kind of standard care for IXT.
3-hour CIAO Therapy Amblyz glasses
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
Amblyopia
It is defined when visual acuity between two eyes equal or over 2 logMAR lines.
Time frame: 3 Months
| Milestone | CIAO Therapy | Observation |
|---|---|---|
| Started | 5 | 3 |
| Completed | 0 | 1 |
| Not completed | 5 | 2 |
| Withdrew: Lost to follow-up | 5 | 2 |
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
| units on a scale | CIAO Therapy | Observation |
|---|---|---|
| Change in Composite Measure of IXT Control Score | — | 5 |
It is defined when visual acuity between two eyes equal or over 2 logMAR lines.
| Participants | CIAO Therapy | Observation |
|---|---|---|
| Amblyopia | 0 | 0 |
Collected over 3MO. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CIAO Therapy | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Observation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Continuous(Year) | CIAO Therapy | Observation | Total |
|---|---|---|---|
| Mean | 5.7 ± 1.94 | 6.24 ± 4.17 | 5.91 ± 2.68 |
| Sex: Female, Male(Participants) | CIAO Therapy | Observation | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | CIAO Therapy | Observation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 3 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| IXT Control Score at distance(units on a scale) | CIAO Therapy | Observation | Total |
|---|---|---|---|
| Mean | 4 ± .71 | 2.67 ± .57 | 3.5 ± .92 |
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2015 to primary completion in Dec 2016, 22 months.
Results were first posted in Nov 2017, 11 months after primary completion.
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This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Indiana University School of Medicine