Binocular Dig Rush Game Treatment for Amblyopia



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:4 - 12
Updated:4/5/2019
Start Date:March 2, 2017
End Date:September 2021
Contact:Raymond Kraker, MSPH
Email:rkraker@jaeb.org
Phone:813-975-8690

Use our guide to learn which trials are right for you!

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.

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.

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)
We found this trial at
62
sites
1949 Gunbarrel Road
Chattanooga, Tennessee 37421
Phone: 423-648-1020
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
4901 Calhoun Road
Houston, Texas 77204
Principal Investigator: Ruth E Manny, O.D., Ph.D.
Phone: 713-743-1944
?
mi
from
Houston, TX
Click here to add this to my saved trials
5460 La Palma Avenue
Anaheim, California 92807
Phone: 714-449-7488
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Atlanta, Georgia 30322
Phone: 404-778-4725
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Phone: 443-849-8082
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland
Principal Investigator: Michael X. Repka, M.D.
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Big Rapids, Michigan 49307
Phone: 231-591-2182
?
mi
from
Big Rapids, MI
Click here to add this to my saved trials
Birmingham, Alabama 35294
Principal Investigator: Kristine Hopkins, O.D.
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bloomington, Indiana 47405
Principal Investigator: Don W. Lyon, O.D.
Phone: 317-856-1964
?
mi
from
Bloomington, IN
Click here to add this to my saved trials
190 East Bannock Street
Boise, Idaho 83712
Phone: 208-381-6910
?
mi
from
Boise, ID
Click here to add this to my saved trials
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-6401
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
?
mi
from
Boston, MA
Click here to add this to my saved trials
Calgary, Alberta
Phone: 403-955-7960
?
mi
from
Calgary,
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-5296
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-6189
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60616
Phone: 312-949-7287
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago Ridge, Illinois 60415
Phone: 708-423-4070
?
mi
from
Chicago Ridge, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45229
Phone: 513-636-4751
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43205
Phone: 614-224-6222
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43210
Principal Investigator: Marjean Kulp, OD, MS
Phone: 614-688-3336
?
mi
from
Columbus, OH
Click here to add this to my saved trials
248 Pleasant Street
Concord, New Hampshire 03301
Phone: 603-224-2020
?
mi
from
Concord, NH
Click here to add this to my saved trials
Durham, North Carolina 27710
Phone: 919-684-2038
?
mi
from
Durham, NC
Click here to add this to my saved trials
128 West 12th Street
Erie, Pennsylvania 16501
Phone: 814-454-6307
?
mi
from
Erie, PA
Click here to add this to my saved trials
Fort Lauderdale, Florida 33382
Phone: 954-262-1426
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Gainesville, Florida 32608
Phone: 352-294-5016
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
5865 West Utopia Road
Glendale, Arizona 85308
Phone: 623-806-7271
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
Phone: 616-267-2605
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
5050 Cascade Road Southeast
Grand Rapids, Michigan 49546
Phone: 616-957-0866
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 832-822-3230
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington, West Virginia 25701
Phone: 304-691-8901
?
mi
from
Huntington, WV
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-356-2877
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Kansas City, Missouri 64108
Phone: 816-701-1337
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lancaster, Pennsylvania 17601
Phone: 717-541-9700
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Laramie, Wyoming 82070
Phone: 307-742-2020
?
mi
from
Laramie, WY
Click here to add this to my saved trials
Lisle, Illinois 60532
Phone: 630-245-0989
?
mi
from
Lisle, IL
Click here to add this to my saved trials
Loma Linda, California 92354
Phone: 909-558-2168
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Lubbock, Texas 79430
Phone: 832-283-1577
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Madison, Wisconsin 53705
Phone: 608-262-3373
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marlton, New Jersey 08053
Phone: 856-988-0080
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
Memphis, Tennessee 38104
Phone: 901-722-3276
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Minneapolis, Minnesota 55454
Phone: 612-625-4120
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mission Viejo, California 92691
Phone: 949-364-0225
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-785-2020
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
33 West 42nd Street
New York, New York 10036
Phone: 212-780-5182
?
mi
from
New York, NY
Click here to add this to my saved trials
880 Kempsville Road
Norfolk, Virginia 23502
Phone: 757-461-0050
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
Phone: 405-271-1094
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-2977
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Poland, Ohio 44514
Phone: 330-746-7691
?
mi
from
Poland, OH
Click here to add this to my saved trials
309 East 2nd Street
Pomona, California 91766
Phone: 909-469-8687
?
mi
from
Pomona, CA
Click here to add this to my saved trials
Portland, Oregon 97205
Phone: 503-224-2323
?
mi
from
Portland, OR
Click here to add this to my saved trials
Portland, Oregon
Phone: 503-494-7830
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rochester, Minnesota 55905
Principal Investigator: Jonathan Holmes, M.D.
Phone: 507-284-3760
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63103
Phone: 313-256-3200
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-454-6026
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63121
Phone: 314-516-5808
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78215
Phone: 210-226-6169
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Schaumburg, Illinois 60194
Phone: 847-891-8003
?
mi
from
Schaumburg, IL
Click here to add this to my saved trials
Seattle, Washington 98105
Principal Investigator: Vivian Manh, O.D., M.S>
Phone: 206-987-4950
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99202
Phone: 509-838-6686
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Spokane, Washington 99204
Phone: 509-456-0107
?
mi
from
Spokane, WA
Click here to add this to my saved trials
1699 Research Forest Drive
The Woodlands, Texas 77381
Phone: 281-351-5468
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
West Des Moines, Iowa 50266
Phone: 800-542-7957
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
3612 Lake Avenue
Wilmette, Illinois 60091
Phone: 847-256-2020
?
mi
from
Wilmette, IL
Click here to add this to my saved trials