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Trial record 1 of 1 for:    ATS18 - Study of Binocular Computer Activities for Treatment of_Amblyopia
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Study of Binocular Computer Activities for Treatment of Amblyopia (ATS18)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02200211
First Posted: July 25, 2014
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
  Purpose
The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play 7 days per week with 2 hours/day patching 7 days per week in children 5 to <17

Condition Intervention
Amblyopia Device: iPad® Other: Patching 2 hours per day, 7 days per week

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Binocular Computer Activities for Treatment of Amblyopia

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • Distance Visual Acuity [ Time Frame: 16 weeks ]
    Monocular distance visual acuity in current refractive correction (if required) in each eye by a certified examiner using the electronic ATS-HOTV visual acuity protocol for children <7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes


Secondary Outcome Measures:
  • Stereoacuity [ Time Frame: 16 weeks ]
    Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests

  • Ocular Alignment [ Time Frame: 16 weeks ]
    Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter)

  • Diplopia Questionnaire [ Time Frame: 16 weeks ]
    The child and parent(s) will be specifically questioned regarding the presence and frequency of any diplopia since the last study visit using a standardized diplopia assessment


Enrollment: 485
Actual Study Start Date: September 11, 2014
Study Completion Date: August 19, 2016
Primary Completion Date: August 19, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Binocular Treatment
Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)
Device: iPad®
Binocular therapy on iPad®
Active Comparator: Patching Treatment
Patching 2 hours per day, 7 days per week
Other: Patching 2 hours per day, 7 days per week
Other Name: Patching

Detailed Description:
The purpose of the study is to 1) compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4 days per week) with 2 hours/day patching 7 days per week, in children 5 to <13 years of age (younger cohort), as a non-inferiority study; and 2) to compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4 days per week) with 2 hours/day patching 7 days per week, in children 13 to <17 years of age (older cohort), as a superiority study.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 5 to <17 years
  2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)

    1. Criteria for strabismus: At least one of the following must be met:

      • Presence of a heterotropia on examination at distance or near fixation (with or without spectacles)
      • Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
    2. Criteria for anisometropia: At least one of the following criteria must be met:

      • ≥0.50 D difference between eyes in spherical equivalent
      • ≥1.50 D difference between eyes in astigmatism in any meridian
    3. Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:

      • Criteria for strabismus are met (see above)
      • ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference between eyes in astigmatism in any meridian
      • Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia
  3. No amblyopia treatment in the past 2 weeks (patching, atropine, Bangerter, vision therapy)
  4. Refractive correction (spectacles or contact lenses, if applicable) must meet the following criteria at enrollment and be based on a cycloplegic refraction that is not more than 7 months old.

    1. Requirements for Correction of Refractive Error:

      1. For subjects meeting criteria for strabismic (only) amblyopia (see 2.2.1 #2 above):

        • Hypermetropia, if corrected, must not be under-corrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes.

      2. For subjects meeting criteria for anisometropic or combined-mechanism amblyopia (see 2.2.1 #2 above):

        • Spherical equivalent must be within 0.50 D of fully correcting the anisometropia
        • Hypermetropia must not be under-corrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes
        • Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism
        • Cylinder axis for both eyes must be within 6 degrees of the axis of the cycloplegic refraction when cylinder power is ≥1.00 D
    2. Refractive corrections meeting the above criteria must be worn for either:

      • 16 weeks or more or
      • Until visual acuity in amblyopic eye is stable (defined as 2 consecutive visual acuity measurements by the same testing method at least 4 weeks apart with <1 line change (<5 letters if E-ETDRS))
    3. Monocular or binocular contact lens wear is allowed provided the contact lenses meet the above refractive requirements at the corneal plane. The same form of correction must be worn throughout the entire study during study procedures (i.e., no changing between contacts and spectacles while patching or while game-playing or study testing). Safety glasses are not required for subjects wearing contact lenses, but investigators are encouraged to suggest safety glasses be worn over contact lenses.
  5. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) within 7 days prior to randomization using the ATS-HOTV visual acuity protocol for children < 7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:

    1. Visual acuity in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters if E-ETDRS)
    2. Visual acuity in the fellow eye 20/25 or better (≥ 78 letters if E-ETDRS)
    3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters if E-ETDRS) (i.e., amblyopic-eye acuity at least 3 logMAR lines worse than fellow-eye acuity)
  6. Heterotropia or heterophoria with a total near deviation of ≤ 10∆ (measured by PACT).
  7. Ability to align the nonius cross on the binocular game system (angles of ocular deviation >10∆ would require the nonius cross to be adjusted to such an extent that playing of the game would be compromised).
  8. Subject is able to play Hess Falling Blocks game on the study iPad® (on easy setting) under binocular conditions (with red-green glasses), as demonstrated by scoring at least 1 line in the office.
  9. Investigator is willing to prescribe computer game play or patching per protocol.
  10. Parent understands the protocol and is willing to accept randomization.
  11. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
  12. Relocation outside of area of an active PEDIG site for this study within the next 16 weeks is not anticipated.

Exclusion Criteria:

A subject is excluded for any of the following reasons:

  1. Prism in the refractive correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
  2. Myopia greater than -6.00D spherical equivalent in either eye.
  3. Previous intraocular or refractive surgery.
  4. Any treatment for amblyopia (patching, atropine, Bangerter filter, or vision therapy) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks immediately prior to enrollment.
  5. Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above visual acuity criteria are met).
  6. No Down syndrome or cerebral palsy
  7. No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
  8. Heterotropia or heterophoria with a total ocular deviation >10∆ (phoria plus tropia >10∆) at near (measured by PACT).
  Contacts and Locations
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): NCT02200211


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Washington
Seattle Children's Hospital, University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Jaeb Center for Health Research
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Investigators
Study Chair: Jonathan Holmes, MD Mayo Clinic
Study Chair: Vivan Manh, OD University of Washington
  More Information

Additional Information:
Publications:
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02200211     History of Changes
Other Study ID Numbers: ATS18
2U10EY011751 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2014
First Posted: July 25, 2014
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.

Keywords provided by Jaeb Center for Health Research:
Amblyopia

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms