Binocular Dig Rush Game Treatment for Amblyopia

NCT ID: NCT02983552

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-02
• Study Completion Date: 2020-07-10

Brief Summary

To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.

Detailed Description

The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.

Conditions

Amblyopia

Study Design

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

Study Groups

Binocular Computer Game Treatment

Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)

Group Type: EXPERIMENTAL

iPad®

Intervention Type: OTHER

Binocular therapy using a Dig Rush application on an iPad®

Continued Spectacle Correction

Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Spectacle correction

Intervention Type: OTHER

Spectacle correction for all waking hours, 7 days per week

Interventions

iPad®

Binocular therapy using a Dig Rush application on an iPad®

Intervention Type: OTHER

Spectacle correction

Spectacle correction for all waking hours, 7 days per week

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 4 to <13 years

2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)

1. Criteria for strabismic amblyopia: At least one of the following must be met:

• Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5pd by SPCT at near fixation (see #6 below)
• 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:

• ≥1.00 D difference between eyes in spherical equivalent
• ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes

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 in astigmatism between corresponding meridians in the two eyes

3. No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment)

4. Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months):

• Hypermetropia of 2.50 D or more by spherical equivalent (SE)
• Myopia of amblyopic eye of 0.50D or more SE
• Astigmatism of 1.00D or more
• Anisometropia of more than 0.50D SE

NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.

1. Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:

• SE must be within 0.50D of fully correcting the anisometropia.
• SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes.
• Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
• Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is >1.00D.
• Myopia must not be undercorrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.

2. Spectacle correction meeting the above criteria must be worn:

• For at least 16 weeks OR until VA stability is documented (defined as <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
• For determining VA stability (non-improvement):

• The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
• The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks.
• Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated.

5. VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for children < 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:

1. VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS)

2. VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS)

3. Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS)

6. Heterotropia with a near deviation of ≤ 5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation >5∆ are not allowed because large magnitudes of the deviation would compromise successful playing of the game.)

7. Subject is able to play the Dig Rush game (at least level 3) on the study iPad under binocular conditions (with red-green glasses). Subject must be able to see both the red "diggers" and blue "gold carts" when contrast for the non-amblyopic eye is at 20%.

8. Investigator is willing to prescribe computer game play, or continued spectacle wear per protocol.

9. Parent understands the protocol and is willing to accept randomization.

10. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.

11. Relocation outside of area of an active PEDIG site for this study within the next 8 weeks is not anticipated.

Exclusion Criteria

1. Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).

2. Myopia greater than -6.00D spherical equivalent in either eye.

3. Previous intraocular or refractive surgery.

4. Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment.

5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above VA 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. Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 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

Ruth Manny, OD, PhD

Role: STUDY_CHAIR

University of Houston College of Optometry

Jonathan Holmes, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama, United States

Midwestern University Eye Institute

Glendale, Arizona, United States

University Eye Center at Ketchum Health

Anaheim, California, United States

Loma Linda University Health Care, Dept. of Ophthalmology

Loma Linda, California, United States

Saddleback Eye Medical Associates

Mission Viejo, California, United States

Western University College of Optometry

Pomona, California, United States

Yale University

New Haven, Connecticut, United States

Nova Southeastern University College of Optometry, The Eye Institute

Fort Lauderdale, Florida, United States

University of Florida Shands Hospital

Gainesville, Florida, United States

The Emory Eye Center

Atlanta, Georgia, United States

St Luke's Hospital

Boise, Idaho, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Illinois College of Optometry

Chicago, Illinois, United States

Ticho Eye Associates

Chicago Ridge, Illinois, United States

Progressive Eye Care

Lisle, Illinois, United States

Advanced Vision Center

Schaumburg, Illinois, United States

Pediatric Eye Associates

Wilmette, Illinois, United States

Indiana School of Optometry

Bloomington, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Wilmer Eye Institute

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Michigan College of Optometry at Ferris State Univ

Big Rapids, Michigan, United States

Helen DeVos Children's Hospital Pediatric Ophthalmology

Grand Rapids, Michigan, United States

Pediatric Ophthalmology, P.C.

Grand Rapids, Michigan, United States

University of Minnesota-Minnesota Lions Children's Eye Clinic

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Saint Louis University Institute

St Louis, Missouri, United States

St. Louis Children's Hospital Eye Center

St Louis, Missouri, United States

U of MO St. Louis College of Optometry

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Concord Ophthalmologic Associates

Concord, New Hampshire, United States

Michael F. Gallaway, O.D., P.C.

Marlton, New Jersey, United States

State University of New York, College of Optometry

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University Eye Center

Durham, North Carolina, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Pediatric Ophthalmology Associates, Inc.

Columbus, Ohio, United States

The Ohio State University College of Optometry

Columbus, Ohio, United States

Eye Care Associates, Inc.

Poland, Ohio, United States

Dean A. McGee Eye Institute, University of Oklahoma

Oklahoma City, Oklahoma, United States

Pacific University College of Optometry

Portland, Oregon, United States

OHSU Casey Eye Institute

Portland, Oregon, United States

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, United States

Conestoga Eye

Lancaster, Pennsylvania, United States

Pediatric Eye Specialists

Chattanooga, Tennessee, United States

Southern College of Optometry

Memphis, Tennessee, United States

Texas Children's Hospital - Dept. Of Ophthalmology

Houston, Texas, United States

University of Houston College of Optometry

Houston, Texas, United States

Texas Tech University Health Science Center

Lubbock, Texas, United States

San Antonio Eye Center

San Antonio, Texas, United States

Houston Eye Associates

The Woodlands, Texas, United States

Virginia Pediatric Eye Center

Norfolk, Virginia, United States

Seattle Children's Hospital, University of Washington

Seattle, Washington, United States

Northwest Pediatric Ophthalmology, P.S.

Spokane, Washington, United States

Spokane Eye Clinical Research

Spokane, Washington, United States

Marshall University

Huntington, West Virginia, United States

University of Wisconsin, University Station

Madison, Wisconsin, United States

Snowy Range Vision Center

Laramie, Wyoming, United States

Alberta Children's Hospital

Calgary, Alberta, Canada

Countries

United States; Canada

References

Pediatric Eye Disease Investigator Group; Holmes JM, Manny RE, Lazar EL, Birch EE, Kelly KR, Summers AI, Martinson SR, Raghuram A, Colburn JD, Law C, Marsh JD, Bitner DP, Kraker RT, Wallace DK. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years. Ophthalmology. 2019 Mar;126(3):456-466. doi: 10.1016/j.ophtha.2018.10.032. Epub 2018 Oct 22.

Reference Type: BACKGROUND

PMID: 30352226 (View on PubMed)

Manny RE, Holmes JM, Kraker RT, Li Z, Waters AL, Kelly KR, Kong L, Crouch ER, Lorenzana IJ, Alkharashi MS, Galvin JA, Rice ML, Melia BM, Cotter SA; Pediatric Eye Disease Investigator Group. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years. Optom Vis Sci. 2022 Mar 1;99(3):213-227. doi: 10.1097/OPX.0000000000001867.

Reference Type: DERIVED

PMID: 35086119 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ATS20

Identifier Type: -

Identifier Source: org_study_id