Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia (CIAO)
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|ClinicalTrials.gov Identifier: NCT02466659|
Recruitment Status : Terminated (no fund)
First Posted : June 9, 2015
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Exotropia||Device: CIAO therapy Amblyz glasses||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia|
|Actual Study Start Date :||February 1, 2015|
|Actual Primary Completion Date :||December 1, 2016|
|Actual Study Completion Date :||December 1, 2016|
Experimental: CIAO Therapy
Intervention with wearing 3-hour daily CIAO therapy glasses
Device: CIAO therapy Amblyz glasses
3-hour CIAO Therapy Amblyz glasses
No Intervention: Observation
To observe as one kind of standard care for IXT.
- Change in Composite Measure of IXT Control Score [ Time Frame: 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
- Amblyopia [ Time Frame: 3 Months ]It is defined when visual acuity between two eyes equal or over 2 logMAR lines.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466659
|United States, Indiana|
|Glick Eye Institute, Indiana University School of Medicine|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Daniel E Neely, MD||Glick Eye Institute|