Study of Binocular Computer Activities for Treatment of Amblyopia

Completed · Not applicable

Conditions studied: Amblyopia

In brief

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

Key facts

Study ID

NCT02200211

Run by

Jaeb Center for Health Research

People needed

485

Starts

2014-09-11

Expected to finish

2016-08-19

Last updated by the study team

2019-02-27

Who can join

Age: 5 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• ≥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))

You may not qualify if…

• 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).
• 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).

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Seattle Children's Hospital, University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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