A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years

Pediatric Eye Disease Investigator Group

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Purpose: To compare visual acuity (VA) improvement in children aged 7 to 12 years with amblyopia treated with a binocular iPad game plus continued spectacle correction vs. continued spectacle correction alone. Design: Multicenter randomized clinical trial. Participants: One hundred thirty-eight participants aged 7 to 12 years with amblyopia (33–72 letters, i.e., approximately 20/200 to 20/40) resulting from strabismus, anisometropia, or both. Participants were required to have at least 16 weeks of optical treatment in spectacles if needed or demonstrate no improvement in amblyopic-eye visual acuity (VA) for at least 8 weeks prior to enrollment. Methods: Eligible participants (mean age 9.6 years, mean baseline VA of 59.6 letters, history of prior amblyopia treatment other than spectacles in 96%) were randomly assigned to treatment for 8 weeks with the dichoptic binocular Dig Rush iPad game (prescribed for 1 hour per day 5 days per week) plus spectacle wear if needed (n = 69) or continued spectacle correction alone if needed (n = 69). Main Outcome Measures: Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. Results: At 4 weeks, mean amblyopic-eye VA letter score improved from baseline by 1.3 (2-sided 95% confidence interval [CI]: 0.1–2.6; 0.026 logMAR) with binocular treatment and by 1.7 (2-sided 95% CI: 0.4–3.0; 0.034 logMAR) with continued spectacle correction alone. After adjusment for baseline VA, the letter score difference between groups (binocular minus control) was -0.3 (95% CI: -2.2 to 1.5, P = 0.71, difference of -0.006 logMAR). No difference in letter scores was observed between groups when the analysis was repeated after 8 weeks of treatment (adjusted mean: -0.1, 98.3% CI: -2.4 to 2.1). For the binocular group, adherence data from the iPad indicated that slightly more than half of the participants (58% and 56%) completed >75% of prescribed treatment by the 4- and 8-week visits, respectively. Conclusions: In children aged 7 to 12 years who have received previous treatment for amblyopia other than spectacles, there was no benefit to VA or stereoacuity from 4 or 8 weeks of treatment with the dichoptic binocular Dig Rush iPad game.

Original languageEnglish (US)
Pages (from-to)456-466
Number of pages11
JournalOphthalmology
Volume126
Issue number3
DOIs
StatePublished - Mar 1 2019

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Amblyopia
Visual Acuity
Confidence Intervals
Therapeutics
Anisometropia
Strabismus
Randomized Controlled Trials
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Ophthalmology

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A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years. / Pediatric Eye Disease Investigator Group.

In: Ophthalmology, Vol. 126, No. 3, 01.03.2019, p. 456-466.

Research output: Contribution to journalArticle

Pediatric Eye Disease Investigator Group. / A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years. In: Ophthalmology. 2019 ; Vol. 126, No. 3. pp. 456-466.
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title = "A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years",
abstract = "Purpose: To compare visual acuity (VA) improvement in children aged 7 to 12 years with amblyopia treated with a binocular iPad game plus continued spectacle correction vs. continued spectacle correction alone. Design: Multicenter randomized clinical trial. Participants: One hundred thirty-eight participants aged 7 to 12 years with amblyopia (33–72 letters, i.e., approximately 20/200 to 20/40) resulting from strabismus, anisometropia, or both. Participants were required to have at least 16 weeks of optical treatment in spectacles if needed or demonstrate no improvement in amblyopic-eye visual acuity (VA) for at least 8 weeks prior to enrollment. Methods: Eligible participants (mean age 9.6 years, mean baseline VA of 59.6 letters, history of prior amblyopia treatment other than spectacles in 96{\%}) were randomly assigned to treatment for 8 weeks with the dichoptic binocular Dig Rush iPad game (prescribed for 1 hour per day 5 days per week) plus spectacle wear if needed (n = 69) or continued spectacle correction alone if needed (n = 69). Main Outcome Measures: Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. Results: At 4 weeks, mean amblyopic-eye VA letter score improved from baseline by 1.3 (2-sided 95{\%} confidence interval [CI]: 0.1–2.6; 0.026 logMAR) with binocular treatment and by 1.7 (2-sided 95{\%} CI: 0.4–3.0; 0.034 logMAR) with continued spectacle correction alone. After adjusment for baseline VA, the letter score difference between groups (binocular minus control) was -0.3 (95{\%} CI: -2.2 to 1.5, P = 0.71, difference of -0.006 logMAR). No difference in letter scores was observed between groups when the analysis was repeated after 8 weeks of treatment (adjusted mean: -0.1, 98.3{\%} CI: -2.4 to 2.1). For the binocular group, adherence data from the iPad indicated that slightly more than half of the participants (58{\%} and 56{\%}) completed >75{\%} of prescribed treatment by the 4- and 8-week visits, respectively. Conclusions: In children aged 7 to 12 years who have received previous treatment for amblyopia other than spectacles, there was no benefit to VA or stereoacuity from 4 or 8 weeks of treatment with the dichoptic binocular Dig Rush iPad game.",
author = "{Pediatric Eye Disease Investigator Group} and Holmes, {Jonathan M.} and Manny, {Ruth E.} and Lazar, {Elizabeth L.} and Birch, {Eileen E.} and Kelly, {Krista R.} and Allison Summers and Martinson, {Stacy R.} and Aparna Raghuram and Colburn, {Jeffrey D.} and Christine Law and Marsh, {Justin D.} and Bitner, {Derek P.} and Kraker, {Raymond T.} and Wallace, {David K.}",
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T1 - A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years

AU - Pediatric Eye Disease Investigator Group

AU - Holmes, Jonathan M.

AU - Manny, Ruth E.

AU - Lazar, Elizabeth L.

AU - Birch, Eileen E.

AU - Kelly, Krista R.

AU - Summers, Allison

AU - Martinson, Stacy R.

AU - Raghuram, Aparna

AU - Colburn, Jeffrey D.

AU - Law, Christine

AU - Marsh, Justin D.

AU - Bitner, Derek P.

AU - Kraker, Raymond T.

AU - Wallace, David K.

PY - 2019/3/1

Y1 - 2019/3/1

N2 - Purpose: To compare visual acuity (VA) improvement in children aged 7 to 12 years with amblyopia treated with a binocular iPad game plus continued spectacle correction vs. continued spectacle correction alone. Design: Multicenter randomized clinical trial. Participants: One hundred thirty-eight participants aged 7 to 12 years with amblyopia (33–72 letters, i.e., approximately 20/200 to 20/40) resulting from strabismus, anisometropia, or both. Participants were required to have at least 16 weeks of optical treatment in spectacles if needed or demonstrate no improvement in amblyopic-eye visual acuity (VA) for at least 8 weeks prior to enrollment. Methods: Eligible participants (mean age 9.6 years, mean baseline VA of 59.6 letters, history of prior amblyopia treatment other than spectacles in 96%) were randomly assigned to treatment for 8 weeks with the dichoptic binocular Dig Rush iPad game (prescribed for 1 hour per day 5 days per week) plus spectacle wear if needed (n = 69) or continued spectacle correction alone if needed (n = 69). Main Outcome Measures: Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. Results: At 4 weeks, mean amblyopic-eye VA letter score improved from baseline by 1.3 (2-sided 95% confidence interval [CI]: 0.1–2.6; 0.026 logMAR) with binocular treatment and by 1.7 (2-sided 95% CI: 0.4–3.0; 0.034 logMAR) with continued spectacle correction alone. After adjusment for baseline VA, the letter score difference between groups (binocular minus control) was -0.3 (95% CI: -2.2 to 1.5, P = 0.71, difference of -0.006 logMAR). No difference in letter scores was observed between groups when the analysis was repeated after 8 weeks of treatment (adjusted mean: -0.1, 98.3% CI: -2.4 to 2.1). For the binocular group, adherence data from the iPad indicated that slightly more than half of the participants (58% and 56%) completed >75% of prescribed treatment by the 4- and 8-week visits, respectively. Conclusions: In children aged 7 to 12 years who have received previous treatment for amblyopia other than spectacles, there was no benefit to VA or stereoacuity from 4 or 8 weeks of treatment with the dichoptic binocular Dig Rush iPad game.

AB - Purpose: To compare visual acuity (VA) improvement in children aged 7 to 12 years with amblyopia treated with a binocular iPad game plus continued spectacle correction vs. continued spectacle correction alone. Design: Multicenter randomized clinical trial. Participants: One hundred thirty-eight participants aged 7 to 12 years with amblyopia (33–72 letters, i.e., approximately 20/200 to 20/40) resulting from strabismus, anisometropia, or both. Participants were required to have at least 16 weeks of optical treatment in spectacles if needed or demonstrate no improvement in amblyopic-eye visual acuity (VA) for at least 8 weeks prior to enrollment. Methods: Eligible participants (mean age 9.6 years, mean baseline VA of 59.6 letters, history of prior amblyopia treatment other than spectacles in 96%) were randomly assigned to treatment for 8 weeks with the dichoptic binocular Dig Rush iPad game (prescribed for 1 hour per day 5 days per week) plus spectacle wear if needed (n = 69) or continued spectacle correction alone if needed (n = 69). Main Outcome Measures: Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. Results: At 4 weeks, mean amblyopic-eye VA letter score improved from baseline by 1.3 (2-sided 95% confidence interval [CI]: 0.1–2.6; 0.026 logMAR) with binocular treatment and by 1.7 (2-sided 95% CI: 0.4–3.0; 0.034 logMAR) with continued spectacle correction alone. After adjusment for baseline VA, the letter score difference between groups (binocular minus control) was -0.3 (95% CI: -2.2 to 1.5, P = 0.71, difference of -0.006 logMAR). No difference in letter scores was observed between groups when the analysis was repeated after 8 weeks of treatment (adjusted mean: -0.1, 98.3% CI: -2.4 to 2.1). For the binocular group, adherence data from the iPad indicated that slightly more than half of the participants (58% and 56%) completed >75% of prescribed treatment by the 4- and 8-week visits, respectively. Conclusions: In children aged 7 to 12 years who have received previous treatment for amblyopia other than spectacles, there was no benefit to VA or stereoacuity from 4 or 8 weeks of treatment with the dichoptic binocular Dig Rush iPad game.

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