TY - JOUR
T1 - An Eye-Tracking–Based Dichoptic Home Treatment for Amblyopia
T2 - A Multicenter Randomized Clinical Trial
AU - the CureSight Pivotal Trial Group
AU - Wygnanski-Jaffe, Tamara
AU - Kushner, Burton J.
AU - Moshkovitz, Avital
AU - Belkin, Michael
AU - Yehezkel, Oren
AU - Gan, Ramat
AU - Spierer, Abraham
AU - Zitzer, Nethanel
AU - Cohen, Dan
AU - Shpigelman, Ahuva
AU - Hadash, Maoz
AU - Ortenberg, Ilya
AU - Cohen, Rinat
AU - Leib, Hana
AU - Arow, Majd
AU - Parness, Reut
AU - Rodov, Luba
AU - Goz, Alexandra
AU - Katz, Haia
AU - Bazov, Anabel
AU - Nissen, Chaim
AU - Avraham, Gabriel
AU - Borsha, Emad
AU - Keynann, Idit
AU - Aviv, Tali
AU - Corcos, Nathalie
AU - Roll, Keren
AU - Mezer, Eedy
AU - Brucker, Vered
AU - Abecassis, Meital
AU - Rabinovich, Ronen
AU - Laster, Eran
AU - Politi, Ronit
AU - Givoni, Hila
AU - Amitirat, Ahed
AU - Barrett, Chiya Robert
AU - Zioni, Adelina
AU - Kuperman, Katty
AU - Crocus, Yael
N1 - Publisher Copyright:
© 2022 American Academy of Ophthalmology
PY - 2023/3
Y1 - 2023/3
N2 - Purpose: Comparing visual outcomes after use of a novel binocular eye-tracking–based home treatment (CureSight; NovaSight, Ltd) with patching. Design: Prospective, multicenter, randomized, masked, controlled, noninferiority pivotal trial. Participants: One hundred three children 4 to < 9 years with anisometropic, small-angle strabismic or mixed-mechanism amblyopia were randomized 1:1 to either CureSight treatment or patching. Methods: The CureSight treatment uses combined anaglyph glasses and an eye tracker to induce real-time blur around the fellow eye fovea in dichoptic streamed video content. Participants used the device for 90 minutes/day, 5 days/week for 16 weeks (120 hours). The patching group received 2 hours of patching 7 days/week (224 hours). The prespecified noninferiority margin was 1 line. Main Outcome Measures: The primary outcome was the improvement in the amblyopic eye visual acuity (VA), modeled with a repeated measures analysis of covariance. Secondary outcomes included stereoacuity, binocular VA, and treatment adherence rates, analyzed by a 1-sample Wilcoxon test within each group and a 2-sample Wilcoxon test comparing groups. Safety outcomes included the frequency and severity of study-related adverse events (AEs). Results: CureSight group VA improvement was found to be noninferior to patching group improvement (0.28 ± 0.13 logarithm of the minimum angle of resolution [logMAR] [P < 0.0001] and 0.23 ± 0.14 logMAR [P < 0.0001], respectively; 90% confidence interval [CI] of difference, –0.008 to 0.076). Stereoacuity improvement of 0.40 log arcseconds (P < 0.0001) and improved binocular VA (0.13 logMAR; P < 0.0001) were observed in the binocular treatment group, with similar improvements in the patching group in stereoacuity (0.40 log arcseconds; P < 0.0001) and binocular VA (0.09 logMAR; P < 0.0001), with no significant difference between improvements in the 2 groups in either stereoacuity (difference, 0; 95% CI, –0.27 to –0.27; P = 0.76) or binocular VA (difference, 0.041; 95% CI, –0.002 to 0.085; P = 0.07). The binocular treatment group had a significantly higher adherence than the patching group (91% vs. 83%; 95% CI, –4.0% to 21%; P = 0.011). No serious AEs were found. Conclusions: Binocular treatment was well tolerated and noninferior to patching in amblyopic children 4 to < 9 years of age. High adherence may provide an alternative treatment option for amblyopia. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
AB - Purpose: Comparing visual outcomes after use of a novel binocular eye-tracking–based home treatment (CureSight; NovaSight, Ltd) with patching. Design: Prospective, multicenter, randomized, masked, controlled, noninferiority pivotal trial. Participants: One hundred three children 4 to < 9 years with anisometropic, small-angle strabismic or mixed-mechanism amblyopia were randomized 1:1 to either CureSight treatment or patching. Methods: The CureSight treatment uses combined anaglyph glasses and an eye tracker to induce real-time blur around the fellow eye fovea in dichoptic streamed video content. Participants used the device for 90 minutes/day, 5 days/week for 16 weeks (120 hours). The patching group received 2 hours of patching 7 days/week (224 hours). The prespecified noninferiority margin was 1 line. Main Outcome Measures: The primary outcome was the improvement in the amblyopic eye visual acuity (VA), modeled with a repeated measures analysis of covariance. Secondary outcomes included stereoacuity, binocular VA, and treatment adherence rates, analyzed by a 1-sample Wilcoxon test within each group and a 2-sample Wilcoxon test comparing groups. Safety outcomes included the frequency and severity of study-related adverse events (AEs). Results: CureSight group VA improvement was found to be noninferior to patching group improvement (0.28 ± 0.13 logarithm of the minimum angle of resolution [logMAR] [P < 0.0001] and 0.23 ± 0.14 logMAR [P < 0.0001], respectively; 90% confidence interval [CI] of difference, –0.008 to 0.076). Stereoacuity improvement of 0.40 log arcseconds (P < 0.0001) and improved binocular VA (0.13 logMAR; P < 0.0001) were observed in the binocular treatment group, with similar improvements in the patching group in stereoacuity (0.40 log arcseconds; P < 0.0001) and binocular VA (0.09 logMAR; P < 0.0001), with no significant difference between improvements in the 2 groups in either stereoacuity (difference, 0; 95% CI, –0.27 to –0.27; P = 0.76) or binocular VA (difference, 0.041; 95% CI, –0.002 to 0.085; P = 0.07). The binocular treatment group had a significantly higher adherence than the patching group (91% vs. 83%; 95% CI, –4.0% to 21%; P = 0.011). No serious AEs were found. Conclusions: Binocular treatment was well tolerated and noninferior to patching in amblyopic children 4 to < 9 years of age. High adherence may provide an alternative treatment option for amblyopia. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
KW - Amblyopia
KW - Binocular treatment
KW - Dichoptic treatment
KW - Eye tracking
KW - Stereopsis
UR - http://www.scopus.com/inward/record.url?scp=85146985896&partnerID=8YFLogxK
U2 - 10.1016/j.ophtha.2022.10.020
DO - 10.1016/j.ophtha.2022.10.020
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???
C2 - 36306974
AN - SCOPUS:85146985896
SN - 0161-6420
VL - 130
SP - 274
EP - 285
JO - Ophthalmology
JF - Ophthalmology
IS - 3
ER -