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Binocular Dig Rush Game Treatment for Amblyopia (ATS20)

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ClinicalTrials.gov Identifier: NCT02983552
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.

Condition or disease Intervention/treatment Phase
Amblyopia Other: iPad® Other: Spectacle correction Not Applicable

Detailed Description:
The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Binocular Dig Rush Game Treatment for Amblyopia
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia Eye Wear

Arm Intervention/treatment
Experimental: Binocular Computer Game Treatment
Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)
Other: iPad®
Binocular therapy using a Dig Rush application on an iPad®

Active Comparator: Continued Spectacle Correction
Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.
Other: Spectacle correction
Spectacle correction for all waking hours, 7 days per week




Primary Outcome Measures :
  1. Mean change in amblyopic-eye VA [ Time Frame: 4 weeks ]
    For both age cohorts, the primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control)


Secondary Outcome Measures :
  1. VA Improvement at 4 Weeks Defined as a Binary Outcome [ Time Frame: At 4 weeks ]
    A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.

  2. VA Improvement at 8 Weeks Defined as a Binary Outcome [ Time Frame: At 8 weeks ]
    A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.

  3. Stereoacuity [ Time Frame: 4 weeks ]
    Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity will be tabulated at baseline and 4 weeks according to treatment group.

  4. Stereoacuity [ Time Frame: 8 weeks ]
    Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity will be tabulated at 8 weeks according to treatment group.

  5. Treatment Compliance with Binocular Therapy [ Time Frame: At 4 weeks ]
    Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment. The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment.

  6. Treatment Compliance with Binocular Therapy at 8 weeks [ Time Frame: At 8 weeks ]
    Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment. The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment.

  7. Fellow-eye Contrast with Binocular Therapy [ Time Frame: 4 weeks ]
    Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment.

  8. Fellow-eye Contrast with Binocular Therapy at 8 Weeks [ Time Frame: 8 weeks ]
    Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment.

  9. VA in Fellow Eye [ Time Frame: 4 weeks ]
    The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.

  10. VA in Fellow Eye at 8 Weeks [ Time Frame: 8 weeks ]
    The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.

  11. Ocular Alignment [ Time Frame: 4 weeks ]
    The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.

  12. Ocular Alignment at 8 Weeks [ Time Frame: 8 weeks ]
    The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.

  13. Diplopia [ Time Frame: 4 weeks ]
    The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. Data will also be tabulated based on the maximum frequency of diplopia reported by treatment group.

  14. Diplopia at 8 Weeks [ Time Frame: 8 weeks ]
    The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. Data will also be tabulated based on the maximum frequency of diplopia reported by treatment group.

  15. Adverse Symptoms [ Time Frame: 4 weeks ]
    The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.

  16. Adverse Symptoms at 8 Weeks [ Time Frame: 8 weeks ]
    The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.


Other Outcome Measures:
  1. Exploratory Analysis: Subgroup Analysis at 4 Weeks [ Time Frame: 4 weeks ]
    The treatment effect after 4 weeks in subgroups based on baseline factors will be assessed in exploratory analyses and used to suggest hypotheses for further investigation in future studies. The following baseline factors are of interest: amblyopic-eye VA, stereoacuity, the presence of a tropia at near, and prior amblyopia treatment (other than spectacle correction). In accordance with NIH guidelines, subgroup analyses of treatment effect according to gender and race/ethnicity will be conducted.



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 4 to <13 years
  2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)

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

      • Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5pd by SPCT at near fixation (see #6 below)
      • 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:

      • ≥1.00 D difference between eyes in spherical equivalent
      • ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
    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 in astigmatism between corresponding meridians in the two eyes
  3. No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment)
  4. Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months):

    • Hypermetropia of 2.50 D or more by spherical equivalent (SE)
    • Myopia of amblyopic eye of 0.50D or more SE
    • Astigmatism of 1.00D or more
    • Anisometropia of more than 0.50D SE

    NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.

    1. Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:

      • SE must be within 0.50D of fully correcting the anisometropia.
      • SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes.
      • Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
      • Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is >1.00D.
      • Myopia must not be undercorrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
    2. Spectacle correction meeting the above criteria must be worn:

      • For at least 16 weeks OR until VA stability is documented (defined as <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
      • For determining VA stability (non-improvement):

        • The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
        • The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks.
        • Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated.
  5. VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for children < 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:

    1. VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS)
    2. VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS)
    3. Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS)
  6. Heterotropia with a near deviation of ≤ 5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation >5∆ are not allowed because large magnitudes of the deviation would compromise successful playing of the game.)
  7. Subject is able to play the Dig Rush game (at least level 3) on the study iPad under binocular conditions (with red-green glasses). Subject must be able to see both the red "diggers" and blue "gold carts" when contrast for the non-amblyopic eye is at 20%.
  8. Investigator is willing to prescribe computer game play, or continued spectacle wear per protocol.
  9. Parent understands the protocol and is willing to accept randomization.
  10. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
  11. Relocation outside of area of an active PEDIG site for this study within the next 8 weeks is not anticipated.

Exclusion Criteria:

  1. Prism in the spectacle 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, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment.
  5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above VA 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. Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)

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): NCT02983552


Contacts
Contact: Raymond Kraker, MSPH 813-975-8690 rkraker@jaeb.org
Contact: Jennifer Shah 813-975-8690 pedig@jaeb.org

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jonathan Holmes, M.D.    507-284-3760    holmes.jonathan@mayo.edu   
Principal Investigator: Jonathan Holmes, M.D.         
United States, Texas
University of Houston College of Optometry Recruiting
Houston, Texas, United States, 77204
Contact: Ruth E Manny, O.D., Ph.D.    713-743-1944    rmanny@central.uh.edu   
Principal Investigator: Ruth E Manny, O.D., Ph.D.         
Sponsors and Collaborators
Jaeb Center for Health Research
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Investigators
Study Chair: Ruth Manny, OD, PhD University of Houston College of Optometry
Study Chair: Jonathan Holmes, MD Mayo Clinic

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02983552     History of Changes
Other Study ID Numbers: ATS20
2U10EY011751 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
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.
Time Frame: Data will be made available after publication of each primary manuscript.
Access Criteria: Users accessing the data must enter an email address.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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