Scott Xiao1, Eric D Gaier2, Hank C Wu3, Endri Angjeli3, Pauline L Nuth3, Lisa I Bohra4, Aaron M Miller5, Malcolm L Mazow6, Ann U Stout6, Christie L Morse7, Louis C Blumenfeld8, Stephen R Glaser9, Eric Crouch10, Noha S Ekdawi11, Don W Lyon12, David I Silbert13, David G Hunter3. 1. Luminopia Inc, Cambridge, Massachusetts. Electronic address: scott@luminopia.com. 2. Luminopia Inc, Cambridge, Massachusetts; Department of Brain and Cognitive Sciences, Picower Institute for Learning and Memory, Massachusetts Institute of Technology, Cambridge. 3. Luminopia Inc, Cambridge, Massachusetts. 4. Children's Eye Care, PC, West Bloomfield, Michigan; Department of Ophthalmology, Wayne State University, Detroit, Michigan; Department of Ophthalmology, William Beaumont School of Medicine, Oakland University, Royal Oak, Michigan. 5. Houston Eye Associates, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas. 6. Houston Eye Associates, Houston, Texas. 7. Concord Ophthalmological Associates, Concord, New Hampshire. 8. Eye Physicians of Central Florida, Maitland. 9. Kids Eye Care of Maryland, Rockville. 10. Virginia Pediatric Eye Center, Virginia Beach, Virginia. 11. Wheaton Eye Clinic, Wheaton, Illinois. 12. Indiana University School of Optometry, Bloomington. 13. Conestoga Eye, Lancaster, Pennsylvania.
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.
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.
Authors: Reed M Jost; Lindsey A Hudgins; Lori M Dao; David R Stager; Becky Luu; Cynthia L Beauchamp; Jeffrey S Hunter; Prashanthi Giridhar; Yi-Zhong Wang; Eileen E Birch Journal: Sci Rep Date: 2022-03-09 Impact factor: 4.379