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

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ClinicalTrials.gov Identifier: NCT02466659
Recruitment Status : Terminated (no fund)
First Posted : June 9, 2015
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel E. Neely, Indiana University

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

Condition or disease Intervention/treatment Phase
Intermittent Exotropia Device: CIAO therapy Amblyz glasses Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Arm Intervention/treatment
Experimental: CIAO Therapy
Intervention with wearing 3-hour daily CIAO therapy glasses
Device: CIAO therapy Amblyz glasses
3-hour CIAO Therapy Amblyz glasses

No Intervention: Observation
To observe as one kind of standard care for IXT.



Primary Outcome Measures :
  1. Change in Composite Measure of IXT Control Score [ Time Frame: 12 weeks; 24 weeks ]

    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



Other Outcome Measures:
  1. Amblyopia [ Time Frame: 3 Months ]
    It is defined when visual acuity between two eyes equal or over 2 logMAR lines.



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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:

  • 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

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): NCT02466659


Locations
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United States, Indiana
Glick Eye Institute, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
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Principal Investigator: Daniel E Neely, MD Glick Eye Institute
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Responsible Party: Daniel E. Neely, Professor of Ophthalmology, Indiana University
ClinicalTrials.gov Identifier: NCT02466659    
Other Study ID Numbers: IndianU
First Posted: June 9, 2015    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daniel E. Neely, Indiana University:
IXT
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases