Recruitment

Recruitment Status
Completed
Estimated Enrollment
512

Inclusion Criterias

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.
Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
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))
...
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.
Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
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))
Presence of a heterotropia on examination at distance or near fixation (with or without spectacles)
Heterotropia or heterophoria with a total near deviation of ≤ 10∆ (measured by PACT).
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.
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.
Age 5 to <17 years
Criteria for strabismus are met (see above)
Visual acuity in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters if E-ETDRS)
No amblyopia treatment in the past 2 weeks (patching, atropine, Bangerter, vision therapy)
Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia
Investigator is willing to prescribe computer game play or patching per protocol.
≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference between eyes in astigmatism in any meridian
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).
Cylinder axis for both eyes must be within 6 degrees of the axis of the cycloplegic refraction when cylinder power is ≥1.00 D
Visual acuity in the fellow eye 20/25 or better (≥ 78 letters if E-ETDRS)
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
16 weeks or more or
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)
Spherical equivalent must be within 0.50 D of fully correcting the anisometropia
Parent understands the protocol and is willing to accept randomization.
≥0.50 diopter (D) difference between eyes in spherical equivalent
Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism
≥1.50 D difference between eyes in astigmatism in any meridian
Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.

Summary

Conditions
Amblyopia
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 16 years
Gender
Both males and females

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...

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.

Inclusion Criterias

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.
Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
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))
...
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.
Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
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))
Presence of a heterotropia on examination at distance or near fixation (with or without spectacles)
Heterotropia or heterophoria with a total near deviation of ≤ 10∆ (measured by PACT).
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.
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.
Age 5 to <17 years
Criteria for strabismus are met (see above)
Visual acuity in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters if E-ETDRS)
No amblyopia treatment in the past 2 weeks (patching, atropine, Bangerter, vision therapy)
Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia
Investigator is willing to prescribe computer game play or patching per protocol.
≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference between eyes in astigmatism in any meridian
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).
Cylinder axis for both eyes must be within 6 degrees of the axis of the cycloplegic refraction when cylinder power is ≥1.00 D
Visual acuity in the fellow eye 20/25 or better (≥ 78 letters if E-ETDRS)
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
16 weeks or more or
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)
Spherical equivalent must be within 0.50 D of fully correcting the anisometropia
Parent understands the protocol and is willing to accept randomization.
≥0.50 diopter (D) difference between eyes in spherical equivalent
Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism
≥1.50 D difference between eyes in astigmatism in any meridian
Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.

Locations

Rochester, Minnesota, 55905
Seattle, Washington, 98105
Rochester, Minnesota, 55905
Seattle, Washington, 98105

Tracking Information

NCT #
NCT02200211
Collaborators
  • Pediatric Eye Disease Investigator Group
  • National Eye Institute (NEI)
Investigators
Study Chair: Jonathan Holmes, MD Mayo Clinic Study Chair: Vivan Manh, OD University of Washington