Study of Binocular Computer Activities for Treatment of Amblyopia

NCT ID: NCT02200211

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 485 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-11
• Study Completion Date: 2016-08-19

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Binocular Treatment

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

Group Type: EXPERIMENTAL

iPad®

Intervention Type: DEVICE

Binocular therapy on iPad®

Patching Treatment

Patching 2 hours per day, 7 days per week

Group Type: ACTIVE_COMPARATOR

Patching 2 hours per day, 7 days per week

Intervention Type: OTHER

Interventions

iPad®

Binocular therapy on iPad®

Intervention Type: DEVICE

Patching 2 hours per day, 7 days per week

Intervention Type: OTHER

Other Intervention Names

Patching

Eligibility 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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Eye Disease Investigator Group

NETWORK

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Holmes, MD

Role: STUDY_CHAIR

Mayo Clinic

Vivan Manh, OD

Role: STUDY_CHAIR

University of Washington

Locations

Mayo Clinic

Rochester, Minnesota, United States

Seattle Children's Hospital, University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27812703 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35129211 (View on PubMed)

Related Links

http://www.pedig.net

PEDIG Public Website

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ATS18

Identifier Type: -

Identifier Source: org_study_id