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Clinical Trial
. 2020 May 20;10(1):8328.
doi: 10.1038/s41598-020-65234-3.

Improved adherence and treatment outcomes with an engaging, personalized digital therapeutic in amblyopia

Scott Xiao  1 , Eric D Gaier  2   3 , Malcolm L Mazow  4 , Ann U Stout  4 , Dean A Travers  2 , Endri Angjeli  2 , Hank C Wu  2 , Gil Binenbaum  5 , David G Hunter  6
Affiliations
Clinical Trial

Improved adherence and treatment outcomes with an engaging, personalized digital therapeutic in amblyopia

Scott Xiao et al. Sci Rep. .

Abstract

Given the prevalence of poor adherence to therapy and the biases of self-reporting across healthcare, we hypothesized that an engaging, personalized therapy may improve adherence and treatment outcomes in the home. We tested this hypothesis in the initial indication of amblyopia, a neurodevelopmental disorder for which available treatments are limited by low adherence. We designed a novel digital therapeutic that modifies patient-selected cinematic content in real-time into therapeutic visual input, while objectively monitoring adherence. The therapeutic design integrated a custom-designed headset that delivers precise visual input to each eye, computational algorithms that apply real-time therapeutic modifications to source content, a cloud-based content management system that enables treatment in the home, and a broad library of licensed content. In a proof-of-concept human study on the therapeutic, we found that amblyopic eye vision improved significantly after 12 weeks of treatment, with higher adherence than that of available treatments. These initial results support the utility of personalized therapy in amblyopia and may have broader relevance for improving treatment outcomes in additional indications.

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Conflict of interest statement

This study was sponsored by Luminopia, Inc. S.X., D.A.T., E.A., and H.C.W. are employees of and have stock options in Luminopia, Inc., S.X. and D.A.T. are officers of Luminopia, Inc. M.L.M. and A.U.S. were provided funding for their involvement in the study as investigators, E.D.G., G.B., and D.G.H. are scientific advisors of and have stock options in Luminopia, Inc. S.X. and D.A.T. are inventors on a pending patent on this work, S.X., D.A.T., and E.D.G. are inventors on a pending patent on a novel amblyopia treatment technology that does not directly relate to this work.

Figures

Figure 1
Figure 1
The Luminopia One Therapeutic. (a) Concept schematic of the custom headset. (b) Software architecture diagram for the therapeutic. (c) Schematic of visual input presented to each eye after therapeutic modifications have been applied to content input. (d) Modified screenshot displaying an example of a patient’s daily usage (in minutes) on the clinical dashboard.
Figure 2
Figure 2
Visual acuity measurements. Mean best-corrected visual acuity in amblyopic and fellow eyes at each study visit across all 10 patients. Data are means ± SEM (n = 10). *p < 0.05 compared to Week 0 (baseline visit), Wilcoxon signed rank test for amblyopic eyes.
Figure 3
Figure 3
Adherence and patient satisfaction measurements. Mean adherence as a percentage of prescribed amount from Week 0 and mean response to NPS question at each follow-up visit across all patients. Data are means ± SEM (n = 10).
Figure 4
Figure 4
Personalization measurements. Unique video count for each patient (n = 10) at study completion.
See this image and copyright information in PMC

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