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Study of Binocular Computer Activities for Treatment of Amblyopia (ATS18)

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.
 
ClinicalTrials.gov Identifier: NCT02200211
Recruitment Status : Completed
First Posted : July 25, 2014
Results First Posted : October 15, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
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 or disease Intervention/treatment Phase
Amblyopia Device: iPad® Other: Patching 2 hours per day, 7 days per week Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Binocular Computer Activities for Treatment of Amblyopia
Actual Study Start Date : September 11, 2014
Actual Primary Completion Date : August 19, 2016
Actual Study Completion Date : August 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years) [ Time Frame: Baseline and 16 weeks ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.


  2. Mean Amblyopic Eye Visual Acuity (Younger Cohort) [ Time Frame: 16 Weeks from baseline ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA.


  3. Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) [ Time Frame: Baseline and 16 weeks ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.


  4. Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) [ Time Frame: 16 weeks ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.


  5. Distribution of Change in Amblyopic-eye Visual Acuity [ Time Frame: Baseline and 16 weeks ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).

    Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).


  6. Distribution of Amblyopic-eye Visual Acuity [ Time Frame: At 16 weeks ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).

    Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).



Secondary Outcome Measures :
  1. Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline [ Time Frame: Baseline and 16-week visit ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).

    Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).


  2. Number of Participants With Resolution of Amblyopia [ Time Frame: 16-week visit ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) for the younger cohort and as letter scores (previously defined) for the older cohort.

    Resolution of amblyopia was defined as having an amblyopic-eye VA of 20/25 or better (≥ 78 letters if E-ETDRS) and within 1 logMAR line (5 letters if E-ETDRS) of the fellow eye VA.


  3. Time Course of Visual Acuity Improvement [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7, higher values indicate poorer VA) and change in VA from baseline as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and follow-up acuities (logMAR) multiplied by 10.


  4. Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups [ Time Frame: Baseline and 16 weeks ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined, positive values indicate improvement), For both descriptive and formal subgroup analyses, all subgroup factors were pre-specified except for baseline stereoacuity (nil, better than nil). We performed post hoc descriptive analyses to explore treatment effect by baseline age (5 to <7 yrs, 7 to <13 yrs) and prior amblyopia treatment (yes/no).


  5. Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups [ Time Frame: Baseline and 16 weeks ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the analyses in the older cohort, the level of VA is measured as letter scores (previously defined) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.

    Subgroup factors of interest were pre-specified except for baseline stereoacuity (nil, better than nil).


  6. Distribution of Stereoacuity Scores [ Time Frame: 16 weeks ]

    Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.

    Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.


  7. Median Stereoacuity Score (Seconds of Arc) [ Time Frame: 16 weeks ]

    Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.

    Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

    A logarithm base 10 transformation was used to convert stereoacuity scores (seconds of arc) to the log scale (conversion reference listed below), which was used to calculate descriptive statistics. Results of the descriptive analyses are reported as seconds of arc.


  8. Distribution of Stereoacuity Scores (Participants With no History of Strabismus) [ Time Frame: 16 weeks ]

    Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.

    Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.


  9. Distribution of Change in Stereoacuity Scores From Baseline [ Time Frame: Baseline and 16 weeks ]

    Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.

    Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000 ) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

    For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 16-week stereoacuity scores.


  10. Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) [ Time Frame: Baseline and 16 weeks ]

    Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.

    Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000 ) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

    For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 16-week stereoacuity scores.


  11. Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data) [ Time Frame: Entire study period, up to 16 weeks ]

    Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.

    The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance. Adherence was calculated as the total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.

    The fellow-eye contrast was initially set to 20% (amblyopic eye always at 100%) and automatically increased or decreased by 10% increments (lowest level of 10%) or left unchanged from the last contrast level, based on the previous day's game play duration (at least 30 minutes required for contrast change) and performance (increased if scored 1000 points or more).

    Post hoc analysis: 4-week fellow-eye contrast.


  12. Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data) [ Time Frame: Entire study period, up to 16 weeks ]

    Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.

    The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance.

    Adherence was calculated as the % of prescribed treatment actually completed: total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.



Other Outcome Measures:
  1. Percentage of Participants Reporting >75% of Prescribed Treatment Completed (Subjective Measures of Adherence) [ Time Frame: 16 Weeks from baseline ]

    Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.

    Parents were asked to record the amount of time that the participant played the binocular game (binocular treatment group) or wore the patch (patching group) each day on a calendar.

    At each study visit, the investigator estimated the frequency and duration of treatment that the participant completed based on the parent-reported calendars and discussion with the participant and/or parent(s). For analysis, the percentage of prescribed treatment completed was calculated as the total number of reported hours of treatment completed since baseline divided by the total number of prescribed hours (refer to the intended treatment dose/frequency listed above) since baseline.


  2. Participants Who Received Non-protocol, Alternative Treatment During the Study [ Time Frame: Entire study period, up to 16 weeks ]

    Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.

    The number of participants who received non-protocol, alternative treatment was tabulated by treatment group.


  3. Safety Analysis: Distribution of the Change in Fellow-eye Visual Acuity From Baseline [ Time Frame: 16-week visit ]
    Monocular distance visual acuity (VA) 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. The change in visual acuity is analyzed as logMAR lines for the younger cohort and as letters for the older cohort.

  4. Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Younger Cohort) [ Time Frame: 16-week visit ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.

    For this safety analysis, the change in fellow-eye visual acuity (logMAR lines) was computed by treatment group, adjusting for baseline visual acuity.


  5. Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Older Cohort) [ Time Frame: 16-week visit ]

    Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

    For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.

    The change in fellow-eye visual acuity (letters) from baseline (positive values indicate improvement) was computed by treatment group, adjusting for baseline visual acuity.


  6. Safety Analysis: Development of a New Tropia and/or Worsening of a Pre-existing Deviation by 10 pd [ 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).

    Participants were classified according to whether they met the any of the following criteria at the 16-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.


  7. Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Parent-reported) [ Time Frame: 16 weeks ]
    A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.

  8. Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Participant-reported) [ Time Frame: 16 weeks ]
    A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.

  9. Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Follow-up (Parent-reported) [ Time Frame: Across study follow-up visits, up to 16 weeks ]
    A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.

  10. Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Study Follow-up (Participant-reported) [ Time Frame: Across study follow-up visits, up to 16 weeks ]
    A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.



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:   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 diopter (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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children < 7 years and the Electronic Early Treatment Diabetic Retinopathy Study (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 Pediatric Eye Disease Investigator Group (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 -6.00 D 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).

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
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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
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Study Chair: Jonathan Holmes, MD Mayo Clinic
Study Chair: Vivan Manh, OD University of Washington

Additional Information:
Publications of Results:
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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 Posted: July 25, 2014    Key Record Dates
Results First Posted: October 15, 2018
Last Update Posted: February 27, 2019
Last Verified: February 2019
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After primary manuscripts are published
Access Criteria: Users accessing the data must enter an email address.
Keywords provided by Jaeb Center for Health Research:
Amblyopia
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms