Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-03 @ 7:50 AM
Study NCT ID:
NCT02466659
Status:
TERMINATED
Last Update Posted:
2017-11-30
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
Sponsor:
Indiana University School of Medicine
Organization:
Study Overview
Official Title:
A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no fund
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIAO
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: