Expired Study
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Indianapolis, Indiana 46202


Purpose:

To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old.


Study summary:

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.


Criteria:

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:


Study is Available At:


Original ID:

IndianU


NCT ID:

NCT02466659


Secondary ID:


Study Acronym:

CIAO


Brief Title:

Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia


Official Title:

A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

3 Years


Maximum Age:

11 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

no fund


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel E Neely, MD
Principal Investigator
Glick Eye Institute

Study Dates

Start Date:February 1, 2015
Completion Date:December 1, 2016
Completion Type:Actual
Primary Completion Date:December 1, 2016
Primary Completion Type:Actual
Verification Date:October 2017
Last Changed Date:October 22, 2017
First Received Date:April 14, 2015
First Results Date:April 20, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in Composite Measure of IXT Control Score
Time Frame:12 weeks; 24 weeks
Safety Issues:False
Description: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 &l

Study Interventions

Intervention Type:Device
Name:CIAO therapy Amblyz glasses
Description:3-hour CIAO Therapy Amblyz glasses
Arm Name:CIAO Therapy

Study Arms

Study Arm Type:No Intervention
Arm Name:Observation
Description:To observe as one kind of standard care for IXT.
Study Arm Type:Experimental
Arm Name:CIAO Therapy
Description:Intervention with wearing 3-hour daily CIAO therapy glasses

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University School of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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