AmblyopiaATS18NCT02200211

Study of Binocular Computer Activities for Treatment of Amblyopia

A study testing iPad® and Patching 2 hours per day, 7 days per week in people with Amblyopia, run by Jaeb Center for Health Research at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 5 to 16 years
Conditions the study is for: Amblyopia
What is being tested?: iPad® and Patching 2 hours per day, 7 days per week
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 485 participants
Where: 2 sitesUnited States
Study dates: 11 Sep 2014to 19 Aug 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age 5 to <17 years
Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
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)
Criteria for anisometropia: At least one of the following criteria must be met:

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≥0.50 diopter (D) difference between eyes in spherical equivalent
≥1.50 D difference between eyes in astigmatism in any meridian
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
No amblyopia treatment in the past 2 weeks (patching, atropine, Bangerter, vision therapy)
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.
Requirements for Correction of Refractive Error:
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.
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
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))
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.
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:
Visual acuity in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters if E-ETDRS)
Visual acuity in the fellow eye 20/25 or better (≥ 78 letters if E-ETDRS)
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)
Heterotropia or heterophoria with a total near deviation of ≤ 10∆ (measured by PACT).
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).
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.
Investigator is willing to prescribe computer game play or patching per protocol.
Parent understands the protocol and is willing to accept randomization.
Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
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.

Who cannot join

A subject is excluded for any of the following reasons:
Prism in the refractive correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
Myopia greater than -6.00 D spherical equivalent in either eye.
Previous intraocular or refractive surgery.
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.
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).

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No Down syndrome or cerebral palsy
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.
Heterotropia or heterophoria with a total ocular deviation >10∆ (phoria plus tropia >10∆) at near (measured by PACT).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Mayo Clinic
Rochester, Minnesota, 55905
Seattle Children's Hospital, University of Washington
Seattle, Washington, 98105

Other trials in United States

About this study

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

Read the 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.

Conditions: Amblyopia
Being tested: iPad®, Patching 2 hours per day, 7 days per week
Keywords: Amblyopia
Medical subject headings: Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iPad®Device
Binocular therapy on iPad®
Patching 2 hours per day, 7 days per weekOther
Also called Patching

Study groups in NCT02200211
Study group	Role	What they receive
Binocular Treatment	Experimental	Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week) Receives: Device: iPad®
Patching Treatment	Active comparator	Patching 2 hours per day, 7 days per week Receives: Other: Patching 2 hours per day, 7 days per week

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years)
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.
Measured: Baseline and 16 weeks
Mean Amblyopic Eye Visual Acuity (Younger Cohort)
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.
Measured: 16 Weeks from baseline
Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)
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.
Measured: Baseline and 16 weeks
Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)
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.
Measured: 16 weeks
Distribution of Change in Amblyopic-eye Visual Acuity
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).
Measured: Baseline and 16 weeks
Distribution of Amblyopic-eye Visual Acuity
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).
Measured: At 16 weeks

Secondary outcomes (12)

Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) 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.
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).
Measured: Baseline and 16-week visit
Number of Participants With Resolution of Amblyopia
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.
Measured: 16-week visit
Time Course of Visual Acuity Improvement
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups
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).
Measured: Baseline and 16 weeks
Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups
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).
Measured: Baseline and 16 weeks
Distribution of Stereoacuity Scores
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.
Measured: 16 weeks
Median Stereoacuity Score (Seconds of Arc)
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.
Measured: 16 weeks
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
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.
Measured: 16 weeks
Distribution of Change in Stereoacuity Scores From Baseline
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.
Measured: Baseline and 16 weeks
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
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.
Measured: Baseline and 16 weeks
Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data)
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.
Measured: Entire study period, up to 16 weeks
Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data)
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.
Measured: Entire study period, up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 201419 Aug 2016

First posted25 Jul 2014 (estimated)
Study start11 Sep 2014
Primary completion19 Aug 2016
Study completion19 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AmblyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 485 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02200211
Sponsor's protocol ID: ATS18
Other IDs: 2U10EY011751
Acronym: ATS18
Status last verified: Feb 2019
First submitted: 23 Jul 2014
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: 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.

Publications

Holmes JM, Manh VM, Lazar EL, Beck RW, Birch EE, Kraker RT, Crouch ER, Erzurum SA, Khuddus N, Summers AI, Wallace DK; Pediatric Eye Disease Investigator Group. Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1391-1400. doi: 10.1001/jamaophthalmol.2016.4262.
PubMed 27812703
Tailor V, Ludden S, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD011347. doi: 10.1002/14651858.CD011347.pub3.
PubMed 35129211

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amblyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Binocular Computer Activities for Treatment of Amblyopia
ClinicalTrials.gov ID: NCT02200211
Acronym / sponsor ID: ATS18 / ATS18
Conditions: Amblyopia
Keywords: Amblyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 485 participants (actual)
Lead sponsor: Jaeb Center for Health ResearchUniversity, hospital or other
Collaborators: Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
Study start: 11 Sep 2014 (actual)
Primary completion: 19 Aug 2016 (actual)
Study completion: 19 Aug 2016 (actual)
First posted: 25 Jul 2014 (estimated)
Results: Posted 15 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Binocular Treatment	Experimental	Device: iPad®Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)
Patching Treatment	Active comparator	Other: Patching 2 hours per day, 7 days per weekPatching 2 hours per day, 7 days per week

Who may qualify

Ages: 5 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (37 listed)

Age 5 to <17 years
Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
No amblyopia treatment in the past 2 weeks (patching, atropine, Bangerter, vision therapy)
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.
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:

Key exclusion criteria (9 listed)

Prism in the refractive correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
Myopia greater than -6.00 D spherical equivalent in either eye.
Previous intraocular or refractive surgery.
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.
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iPad®Binocular therapy on iPad®	Device	Binocular Treatment
Patching 2 hours per day, 7 days per weekAlso: Patching	Other	Patching Treatment

Primary outcome

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.
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.
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.
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.
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).
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).

12 secondary outcomes

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
Number of Participants With Resolution of Amblyopia
Time frame: 16-week visit
Time Course of Visual Acuity Improvement
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups
Time frame: Baseline and 16 weeks
Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups
Time frame: Baseline and 16 weeks
Distribution of Stereoacuity Scores
Time frame: 16 weeks
Median Stereoacuity Score (Seconds of Arc)
Time frame: 16 weeks
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Time frame: 16 weeks
Distribution of Change in Stereoacuity Scores From Baseline
Time frame: Baseline and 16 weeks
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Time frame: Baseline and 16 weeks
Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data)
Time frame: Entire study period, up to 16 weeks
Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data)
Time frame: Entire study period, up to 16 weeks

Results and safety

Results posted to the registry on 15 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Binocular Treatment Younger	190	182
Patching Treatment Younger	195	188
Binocular Treatment Older	40	39
Patching Treatment Older	60	58

Primary outcome: Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years)

Time frame: Baseline and 16 weeks. Mean (95% Confidence Interval). Unit: LogMAR lines

Measure	Binocular Treatment Younger n = 177	Patching Treatment Younger n = 186
Adjusted for baseline VA and age	1.05 (0.85 to 1.24)	1.35 (1.17 to 1.54)
Unadjusted	1.08 (0.86 to 1.29)	1.32 (1.14 to 1.51)

Binocular Treatment Younger vs Patching Treatment Younger: Mean Difference (Final Values): 0.31
Binocular Treatment Younger vs Patching Treatment Younger: Mean Difference (Final Values): 0.30
Binocular Treatment Younger vs Patching Treatment Younger: Mean Difference (Final Values): 0.31

Population analysed: Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to \<20 weeks after randomization), analysis is adjusted for baseline covariates of age and visual acuity.

Primary outcome: Mean Amblyopic Eye Visual Acuity (Younger Cohort)

Time frame: 16 Weeks from baseline. Mean (Standard Deviation). Unit: LogMAR

Measure	Binocular Treatment Younger n = 177	Patching Treatment Younger n = 186
Value	0.41 (0.21)	0.35 (0.20)

Population analysed: Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to \<20 weeks after randomization).

Primary outcome: Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)

Time frame: Baseline and 16 weeks. Mean (95% Confidence Interval). Unit: letters

Measure	Binocular Treatment Older n = 39	Patching Treatment Older n = 56
Unadjusted	3.5 (1.3 to 5.7)	6.5 (4.4 to 8.5)
Adjusted for baseline visual acuity	3.7 (1.3 to 6.0)	6.3 (4.4 to 8.3)

Binocular Treatment Older vs Patching Treatment Older: Mean Difference (Final Values): -2.7 (95% CI -5.7 to 0.3), p = 0.082, ANCOVA
Binocular Treatment Older vs Patching Treatment Older: Mean Difference (Final Values): -2.7 (95% CI -5.9 to 0.5)
Binocular Treatment Older vs Patching Treatment Older: Mean Difference (Final Values): -2.8 (95% CI -5.9 to 0.3)

Population analysed: Mean change in amblyopic-eye visual acuity from baseline to 16 weeks from participants who completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)

Primary outcome: Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)

Time frame: 16 weeks. Mean (Standard Deviation). Unit: letters

Measure	Binocular Treatment Older n = 39	Patching Treatment Older n = 56
Value	62.0 (9.7)	62.5 (11.6)

Population analysed: Participants that completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Binocular Treatment Younger	0 of 190 (0%)	0 of 190 (0%)	Not reported
Patching Treatment Younger	0 of 195 (0%)	0 of 195 (0%)	Not reported
Binocular Treatment Older	0 of 40 (0%)	0 of 40 (0%)	Not reported
Patching Treatment Older	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27812703Holmes JM, Manh VM, Lazar EL, Beck RW, Birch EE, Kraker RT, Crouch ER, Erzurum SA, Khuddus N, Summers AI, Wallace DK; Pediatric Eye Disease Investigator Group. Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1391-1400. doi: 10.1001/jamaophthalmol.2016.4262.
Derived from this study: PubMed 35129211Tailor V, Ludden S, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD011347. doi: 10.1002/14651858.CD011347.pub3.
PEDIG Public WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonathan Holmes, MD study chair

Mayo Clinic

Vivan Manh, OD study chair

University of Washington

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing iPad® and Patching 2 hours per day, 7 days per week in people with Amblyopia, run by Jaeb Center for Health Research at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years) (time frame: Baseline and 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02200211, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.