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Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia (CIAO)

Primary Purpose

Intermittent Exotropia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CIAO therapy Amblyz glasses
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia focused on measuring IXT

Eligibility Criteria

3 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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:

  • N/A

Sites / Locations

  • Glick Eye Institute, Indiana University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CIAO Therapy

Observation

Arm Description

Intervention with wearing 3-hour daily CIAO therapy glasses

To observe as one kind of standard care for IXT.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 14, 2015
Last Updated
October 22, 2017
Sponsor
Indiana University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02466659
Brief Title
Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
Acronym
CIAO
Official Title
A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
no fund
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Exotropia
Keywords
IXT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIAO Therapy
Arm Type
Experimental
Arm Description
Intervention with wearing 3-hour daily CIAO therapy glasses
Arm Title
Observation
Arm Type
No Intervention
Arm Description
To observe as one kind of standard care for IXT.
Intervention Type
Device
Intervention Name(s)
CIAO therapy Amblyz glasses
Intervention Description
3-hour CIAO Therapy Amblyz glasses
Primary Outcome Measure Information:
Title
Change in Composite Measure of IXT Control Score
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 < 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
Other Pre-specified Outcome Measures:
Title
Amblyopia
Description
It is defined when visual acuity between two eyes equal or over 2 logMAR lines.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel E Neely, MD
Organizational Affiliation
Glick Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glick Eye Institute, Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

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