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

Primary Purpose

Intermittent Exotropia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled Intermittent Alternate Occlusion (CIAO ) glasses
Sponsored by
Salus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia

Eligibility Criteria

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

Inclusion Criteria:

The following criteria must be met for the patient to be enrolled in the study:

  1. Age 3 to 11 years old
  2. 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 10PD at distance OR 15PD at near measured by prism and alternate cover test (PACT)
  3. No previous surgical or non-surgical treatment for IXT (other than refractive correction)
  4. Visual acuity in the worse eye 20/40 (0.3 logMAR) or better on ATS HOTV for ages 3 - 5 and 20/25 (0.1 logMAR) or better on ATS HOTV for ages 6 - 11
  5. No hyperopia greater than +3.50 D spherical equivalent in either eye
  6. No myopia greater than -6.00 D spherical equivalent in either eye
  7. Patients must be wearing refractive correction (spectacles or contact lenses) for at least one week if refractive error (based on cycloplegic refraction performed within 6 months) meets any of the following:

    • Myopia > -0.50 D spherical equivalent in either eye
    • Anisometropia > 1.00 D spherical equivalent
    • Astigmatism in either eye > 2.00 D if ≤ 5 years old and > 1.50 D if > 5 years old

    Refractive correction for patients meeting the above refractive error criteria must meet the following guidelines:

    • Anisometropia spherical equivalent must be within 0.25D of the full anisometropic difference correction
    • Astigmatism cylinder must be within 0.25D of full correction and axis must be within 5 degrees of full correction.
    • For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical. Prescribing any refractive correction to yield lenses that are more myopic than -0.50 D spherical equivalent (SE) is considered deliberate overminus and is not allowed at enrollment. However, prescribing no correction or prescribing less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol and is allowed because most patients without IXT but with hyperopic SE refractions in this range would not typically be prescribed a refractive correction.
    • For myopia, the intent is to fully correct, but the spherical component can be undercorrected by investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed at enrollment.

    Note that the refractive correction guidelines and the requirement to wear refractive correction for at least one week apply not only to patients who require refractive correction under the above criteria but also to any other patient who is wearing refractive correction.

  8. No atropine use within the last week
  9. Gestational age > 34 weeks and birth weight > 1500 grams
  10. Patient and/or parent is willing to accept randomization to either observation or CIAO therapy.
  11. Parent has a phone (or access to phone) and is willing to be contacted

Exclusion Criteria:

  1. Only phoria at both distance and near
  2. Prior non-surgical treatment for IXT other than refractive correction (e.g., vergence therapy, occlusion, vision therapy/orthoptics, or deliberate over-minus with spectacles more than 0.50D)
  3. Previous amblyopia treatment other than refractive correction within 1 year
  4. Vision therapy/orthoptics for any reason within the last year
  5. Interocular visual acuity difference more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to < 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old)
  6. Investigator planning to initiate amblyopia treatment

Sites / Locations

  • Salus UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Monitored CIAO therapy

Observation

Arm Description

Participants wear 3-hour CIAO therapy

No intervention, just observation

Outcomes

Primary Outcome Measures

Control of the exodeviation assessment (scaled 1-5)
Intermittent Exotropia Control Scale (1-5) 5 = Constant exotropia 4 = Exotropia > 50% of the 30-second period before dissociation 3 = Exotropia < 50% of the 30-second period before dissociation 2 = No exotropia unless dissociated, recovers in > 5 seconds 1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in < 1 second (phoria)

Secondary Outcome Measures

Full Information

First Posted
May 8, 2016
Last Updated
April 3, 2019
Sponsor
Salus University
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1. Study Identification

Unique Protocol Identification Number
NCT02902887
Brief Title
Monitored 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salus University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study presents an opportunity to understand a novel, previously unreported controlled intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of Intermittent exotropia (IXT).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monitored CIAO therapy
Arm Type
Experimental
Arm Description
Participants wear 3-hour CIAO therapy
Arm Title
Observation
Arm Type
No Intervention
Arm Description
No intervention, just observation
Intervention Type
Device
Intervention Name(s)
Controlled Intermittent Alternate Occlusion (CIAO ) glasses
Intervention Description
Monitored CIAO therapy glasses
Primary Outcome Measure Information:
Title
Control of the exodeviation assessment (scaled 1-5)
Description
Intermittent Exotropia Control Scale (1-5) 5 = Constant exotropia 4 = Exotropia > 50% of the 30-second period before dissociation 3 = Exotropia < 50% of the 30-second period before dissociation 2 = No exotropia unless dissociated, recovers in > 5 seconds 1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in < 1 second (phoria)
Time Frame
3-month

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: The following criteria must be met for the patient to be enrolled in the study: Age 3 to 11 years old 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 10PD at distance OR 15PD at near measured by prism and alternate cover test (PACT) No previous surgical or non-surgical treatment for IXT (other than refractive correction) Visual acuity in the worse eye 20/40 (0.3 logMAR) or better on ATS HOTV for ages 3 - 5 and 20/25 (0.1 logMAR) or better on ATS HOTV for ages 6 - 11 No hyperopia greater than +3.50 D spherical equivalent in either eye No myopia greater than -6.00 D spherical equivalent in either eye Patients must be wearing refractive correction (spectacles or contact lenses) for at least one week if refractive error (based on cycloplegic refraction performed within 6 months) meets any of the following: Myopia > -0.50 D spherical equivalent in either eye Anisometropia > 1.00 D spherical equivalent Astigmatism in either eye > 2.00 D if ≤ 5 years old and > 1.50 D if > 5 years old Refractive correction for patients meeting the above refractive error criteria must meet the following guidelines: Anisometropia spherical equivalent must be within 0.25D of the full anisometropic difference correction Astigmatism cylinder must be within 0.25D of full correction and axis must be within 5 degrees of full correction. For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical. Prescribing any refractive correction to yield lenses that are more myopic than -0.50 D spherical equivalent (SE) is considered deliberate overminus and is not allowed at enrollment. However, prescribing no correction or prescribing less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol and is allowed because most patients without IXT but with hyperopic SE refractions in this range would not typically be prescribed a refractive correction. For myopia, the intent is to fully correct, but the spherical component can be undercorrected by investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed at enrollment. Note that the refractive correction guidelines and the requirement to wear refractive correction for at least one week apply not only to patients who require refractive correction under the above criteria but also to any other patient who is wearing refractive correction. No atropine use within the last week Gestational age > 34 weeks and birth weight > 1500 grams Patient and/or parent is willing to accept randomization to either observation or CIAO therapy. Parent has a phone (or access to phone) and is willing to be contacted Exclusion Criteria: Only phoria at both distance and near Prior non-surgical treatment for IXT other than refractive correction (e.g., vergence therapy, occlusion, vision therapy/orthoptics, or deliberate over-minus with spectacles more than 0.50D) Previous amblyopia treatment other than refractive correction within 1 year Vision therapy/orthoptics for any reason within the last year Interocular visual acuity difference more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to < 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old) Investigator planning to initiate amblyopia treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyun Wang, PhD
Phone
215-780-1376
Email
jwang@salus.edu
Facility Information:
Facility Name
Salus University
City
Elkins Park
State/Province
Pennsylvania
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyun Wang

12. IPD Sharing Statement

Plan to Share IPD
No

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

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