Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study
| Autor: | Stephen R. Glaser, David G. Hunter, Lisa I. Bohra, Malcolm L. Mazow, Pauline L. Nuth, Eric R. Crouch, Endri Angjeli, Noha S. Ekdawi, Christie L. Morse, Hank C. Wu, Scott Xiao, Don W. Lyon, Louis C. Blumenfeld, Eric D. Gaier, David I. Silbert, Ann U. Stout, Aaron M. Miller |
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| Rok vydání: | 2021 |
| Předmět: |
Visual acuity
genetic structures Visual Acuity Pilot Projects Amblyopia Poor adherence 03 medical and health sciences 0302 clinical medicine Clinical endpoint Humans Medicine Prospective Studies Child Prospective cohort study Prior treatment business.industry eye diseases Stereoscopic acuity Ophthalmology Treatment Outcome Child Preschool Pediatrics Perinatology and Child Health Cohort 030221 ophthalmology & optometry Optometry Sensory Deprivation Open label medicine.symptom business Follow-Up Studies |
| Zdroj: | Journal of American Association for Pediatric Ophthalmology and Strabismus. 25:87.e1-87.e6 |
| ISSN: | 1091-8531 |
| Popis: | 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.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.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%).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. |
| Databáze: | OpenAIRE |
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