Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study

Scott Xiao; Eric D. Gaier; Hank C. Wu; Endri Angjeli; Pauline L. Nuth; Lisa I. Bohra; Aaron M. Miller; Malcolm L. Mazow; Ann U. Stout; Christie L. Morse; Louis C. Blumenfeld; Stephen R. Glaser; Eric Crouch; Noha S. Ekdawi; Don W. Lyon; David I. Silbert; David G. Hunter

doi:10.1016/j.jaapos.2020.11.022

Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study

Scott Xiao, Eric D. Gaier, Hank C. Wu, Endri Angjeli, Pauline L. Nuth, Lisa I. Bohra, Aaron M. Miller, Malcolm L. Mazow, Ann U. Stout, Christie L. Morse, Louis C. Blumenfeld, Stephen R. Glaser, Eric Crouch, Noha S. Ekdawi, Don W. Lyon, David I. Silbert, David G. Hunter

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

Abstract

BACKGROUND: The effectiveness of amblyopia therapy can be limited by poor adherence. Dichoptic therapies are a new approach, but recent trials have demonstrated difficulty maintaining high adherence over extended periods of at-home treatment. We evaluated the efficacy and adherence of Luminopia One-a dichoptic treatment that applies therapeutic modifications to streaming content chosen by the patient.

METHODS: This single-arm, multicenter prospective pilot study enrolled children aged 4-12 with anisometropic, strabismic, or mixed amblyopia at 10 pediatric ophthalmic and optometric practices across the United States. The therapeutic was prescribed for 1 hour/day, 6 days/week for 12 weeks of at-home use. The primary endpoint was best-corrected visual acuity (BCVA) at the 12-week follow-up visit.

RESULTS: In total, 90 participants (mean age, 6.7 ± 2.0 years) were enrolled, and 73/90 participants (81%) had prior treatment beyond refractive correction. For those who completed the 12-week visit, mean amblyopic eye BCVA improved from 0.50 logMAR to 0.35 logMAR (1.5 logMAR lines; 95% CI, 1.2-1.8 lines; P < 0.0001). Mean stereoacuity improved by 0.28 log arcsec (95% CI, 0.14-0.42 log arcsec; P < 0.0001). Median adherence was 86% (interquartile range, 70%-97%).

CONCLUSIONS: In our study cohort, adherence over the 12-week study period was high, and participants demonstrated clinically and statistically significant improvements in visual acuity and stereoacuity.

Original language	English (US)
Pages (from-to)	87.e1-87.e6
Journal	Journal of AAPOS
Volume	25
Issue number	2
DOIs	https://doi.org/10.1016/j.jaapos.2020.11.022
State	Published - Apr 2021

Keywords

Amblyopia/therapy
Child
Child, Preschool
Follow-Up Studies
Humans
Pilot Projects
Prospective Studies
Sensory Deprivation
Treatment Outcome
Visual Acuity

ASJC Scopus subject areas

Ophthalmology
Pediatrics, Perinatology, and Child Health

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10.1016/j.jaapos.2020.11.022

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Xiao, S., Gaier, E. D., Wu, H. C., Angjeli, E., Nuth, P. L., Bohra, L. I., Miller, A. M., Mazow, M. L., Stout, A. U., Morse, C. L., Blumenfeld, L. C., Glaser, S. R., Crouch, E., Ekdawi, N. S., Lyon, D. W., Silbert, D. I., & Hunter, D. G. (2021). Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study. Journal of AAPOS, 25(2), 87.e1-87.e6. https://doi.org/10.1016/j.jaapos.2020.11.022

Xiao, S, Gaier, ED, Wu, HC, Angjeli, E, Nuth, PL, Bohra, LI, Miller, AM, Mazow, ML, Stout, AU, Morse, CL, Blumenfeld, LC, Glaser, SR, Crouch, E, Ekdawi, NS, Lyon, DW, Silbert, DI & Hunter, DG 2021, 'Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study', Journal of AAPOS, vol. 25, no. 2, pp. 87.e1-87.e6. https://doi.org/10.1016/j.jaapos.2020.11.022

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title = "Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study",

abstract = "BACKGROUND: The effectiveness of amblyopia therapy can be limited by poor adherence. Dichoptic therapies are a new approach, but recent trials have demonstrated difficulty maintaining high adherence over extended periods of at-home treatment. We evaluated the efficacy and adherence of Luminopia One-a dichoptic treatment that applies therapeutic modifications to streaming content chosen by the patient.METHODS: This single-arm, multicenter prospective pilot study enrolled children aged 4-12 with anisometropic, strabismic, or mixed amblyopia at 10 pediatric ophthalmic and optometric practices across the United States. The therapeutic was prescribed for 1 hour/day, 6 days/week for 12 weeks of at-home use. The primary endpoint was best-corrected visual acuity (BCVA) at the 12-week follow-up visit.RESULTS: In total, 90 participants (mean age, 6.7 ± 2.0 years) were enrolled, and 73/90 participants (81%) had prior treatment beyond refractive correction. For those who completed the 12-week visit, mean amblyopic eye BCVA improved from 0.50 logMAR to 0.35 logMAR (1.5 logMAR lines; 95% CI, 1.2-1.8 lines; P < 0.0001). Mean stereoacuity improved by 0.28 log arcsec (95% CI, 0.14-0.42 log arcsec; P < 0.0001). Median adherence was 86% (interquartile range, 70%-97%).CONCLUSIONS: In our study cohort, adherence over the 12-week study period was high, and participants demonstrated clinically and statistically significant improvements in visual acuity and stereoacuity.",

keywords = "Amblyopia/therapy, Child, Child, Preschool, Follow-Up Studies, Humans, Pilot Projects, Prospective Studies, Sensory Deprivation, Treatment Outcome, Visual Acuity",

author = "Scott Xiao and Gaier, {Eric D.} and Wu, {Hank C.} and Endri Angjeli and Nuth, {Pauline L.} and Bohra, {Lisa I.} and Miller, {Aaron M.} and Mazow, {Malcolm L.} and Stout, {Ann U.} and Morse, {Christie L.} and Blumenfeld, {Louis C.} and Glaser, {Stephen R.} and Eric Crouch and Ekdawi, {Noha S.} and Lyon, {Don W.} and Silbert, {David I.} and Hunter, {David G.}",

note = "Funding Information: Financial disclosures: This study was sponsored by Luminopia Inc. SX, EA, and HCW are employees of and have stock options in Luminopia Inc. SX is an officer of Luminopia Inc. EDG and DGH are scientific advisors of and have stock options in Luminopia Inc. SX is an inventor on a pending patent on this work. SX and EDG are inventors on a pending patent on amblyopia treatment technology that does not relate directly to this work.Funding: Research sponsored by Luminopia Inc. The sponsor was involved in developing the therapeutic, designing and conducting the study, analyzing the data, and the decision to submit this article for publication. Funding Information: Financial disclosures: This study was sponsored by Luminopia Inc. SX, EA, and HCW are employees of and have stock options in Luminopia Inc. SX is an officer of Luminopia Inc. EDG and DGH are scientific advisors of and have stock options in Luminopia Inc. SX is an inventor on a pending patent on this work. SX and EDG are inventors on a pending patent on amblyopia treatment technology that does not relate directly to this work. Publisher Copyright: {\textcopyright} 2021 American Association for Pediatric Ophthalmology and Strabismus",

year = "2021",

month = apr,

doi = "10.1016/j.jaapos.2020.11.022",

language = "English (US)",

volume = "25",

pages = "87.e1--87.e6",

journal = "Journal of AAPOS",

issn = "1091-8531",

publisher = "Mosby Inc.",

number = "2",

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TY - JOUR

T1 - Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study

AU - Xiao, Scott

AU - Gaier, Eric D.

AU - Wu, Hank C.

AU - Angjeli, Endri

AU - Nuth, Pauline L.

AU - Bohra, Lisa I.

AU - Miller, Aaron M.

AU - Mazow, Malcolm L.

AU - Stout, Ann U.

AU - Morse, Christie L.

AU - Blumenfeld, Louis C.

AU - Glaser, Stephen R.

AU - Crouch, Eric

AU - Ekdawi, Noha S.

AU - Lyon, Don W.

AU - Silbert, David I.

AU - Hunter, David G.

N1 - Funding Information: Financial disclosures: This study was sponsored by Luminopia Inc. SX, EA, and HCW are employees of and have stock options in Luminopia Inc. SX is an officer of Luminopia Inc. EDG and DGH are scientific advisors of and have stock options in Luminopia Inc. SX is an inventor on a pending patent on this work. SX and EDG are inventors on a pending patent on amblyopia treatment technology that does not relate directly to this work.Funding: Research sponsored by Luminopia Inc. The sponsor was involved in developing the therapeutic, designing and conducting the study, analyzing the data, and the decision to submit this article for publication. Funding Information: Financial disclosures: This study was sponsored by Luminopia Inc. SX, EA, and HCW are employees of and have stock options in Luminopia Inc. SX is an officer of Luminopia Inc. EDG and DGH are scientific advisors of and have stock options in Luminopia Inc. SX is an inventor on a pending patent on this work. SX and EDG are inventors on a pending patent on amblyopia treatment technology that does not relate directly to this work. Publisher Copyright: © 2021 American Association for Pediatric Ophthalmology and Strabismus

PY - 2021/4

Y1 - 2021/4

N2 - BACKGROUND: The effectiveness of amblyopia therapy can be limited by poor adherence. Dichoptic therapies are a new approach, but recent trials have demonstrated difficulty maintaining high adherence over extended periods of at-home treatment. We evaluated the efficacy and adherence of Luminopia One-a dichoptic treatment that applies therapeutic modifications to streaming content chosen by the patient.METHODS: This single-arm, multicenter prospective pilot study enrolled children aged 4-12 with anisometropic, strabismic, or mixed amblyopia at 10 pediatric ophthalmic and optometric practices across the United States. The therapeutic was prescribed for 1 hour/day, 6 days/week for 12 weeks of at-home use. The primary endpoint was best-corrected visual acuity (BCVA) at the 12-week follow-up visit.RESULTS: In total, 90 participants (mean age, 6.7 ± 2.0 years) were enrolled, and 73/90 participants (81%) had prior treatment beyond refractive correction. For those who completed the 12-week visit, mean amblyopic eye BCVA improved from 0.50 logMAR to 0.35 logMAR (1.5 logMAR lines; 95% CI, 1.2-1.8 lines; P < 0.0001). Mean stereoacuity improved by 0.28 log arcsec (95% CI, 0.14-0.42 log arcsec; P < 0.0001). Median adherence was 86% (interquartile range, 70%-97%).CONCLUSIONS: In our study cohort, adherence over the 12-week study period was high, and participants demonstrated clinically and statistically significant improvements in visual acuity and stereoacuity.

AB - BACKGROUND: The effectiveness of amblyopia therapy can be limited by poor adherence. Dichoptic therapies are a new approach, but recent trials have demonstrated difficulty maintaining high adherence over extended periods of at-home treatment. We evaluated the efficacy and adherence of Luminopia One-a dichoptic treatment that applies therapeutic modifications to streaming content chosen by the patient.METHODS: This single-arm, multicenter prospective pilot study enrolled children aged 4-12 with anisometropic, strabismic, or mixed amblyopia at 10 pediatric ophthalmic and optometric practices across the United States. The therapeutic was prescribed for 1 hour/day, 6 days/week for 12 weeks of at-home use. The primary endpoint was best-corrected visual acuity (BCVA) at the 12-week follow-up visit.RESULTS: In total, 90 participants (mean age, 6.7 ± 2.0 years) were enrolled, and 73/90 participants (81%) had prior treatment beyond refractive correction. For those who completed the 12-week visit, mean amblyopic eye BCVA improved from 0.50 logMAR to 0.35 logMAR (1.5 logMAR lines; 95% CI, 1.2-1.8 lines; P < 0.0001). Mean stereoacuity improved by 0.28 log arcsec (95% CI, 0.14-0.42 log arcsec; P < 0.0001). Median adherence was 86% (interquartile range, 70%-97%).CONCLUSIONS: In our study cohort, adherence over the 12-week study period was high, and participants demonstrated clinically and statistically significant improvements in visual acuity and stereoacuity.

KW - Amblyopia/therapy

KW - Child

KW - Child, Preschool

KW - Follow-Up Studies

KW - Humans

KW - Pilot Projects

KW - Prospective Studies

KW - Sensory Deprivation

KW - Treatment Outcome

KW - Visual Acuity

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U2 - 10.1016/j.jaapos.2020.11.022

DO - 10.1016/j.jaapos.2020.11.022

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C2 - 33905837

AN - SCOPUS:85106357838

SN - 1091-8531

VL - 25

SP - 87.e1-87.e6

JO - Journal of AAPOS

JF - Journal of AAPOS

IS - 2

ER -

Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study

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ASJC Scopus subject areas

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