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

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ClinicalTrials.gov Identifier: NCT02902887
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Salus University

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).

Condition or disease Intervention/treatment Phase
Intermittent Exotropia Device: Controlled Intermittent Alternate Occlusion (CIAO ) glasses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
Actual Study Start Date : August 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: Monitored CIAO therapy
Participants wear 3-hour CIAO therapy
Device: Controlled Intermittent Alternate Occlusion (CIAO ) glasses
Monitored CIAO therapy glasses

No Intervention: Observation
No intervention, just observation



Primary Outcome Measures :
  1. Control of the exodeviation assessment (scaled 1-5) [ Time Frame: 3-month ]

    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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02902887


Contacts
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Contact: Jingyun Wang, PhD 215-780-1376 jwang@salus.edu

Locations
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United States, Pennsylvania
Salus University Recruiting
Elkins Park, Pennsylvania, United States
Contact: Jingyun Wang         
Sponsors and Collaborators
Salus University
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Responsible Party: Salus University
ClinicalTrials.gov Identifier: NCT02902887    
Other Study ID Numbers: HJW1601
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases