Abstract
Purpose :
To assess the hurdles and challenges when studying amblyopia therapy for clinical practice.
Methods :
Since December 2017 newly diagnosed amblyopic children ≥4 years with interocular visual acuity (VA) difference ≥0.2 logMAR were recruited for this ongoing RCT. Prior to randomization children received 16 weeks of refractive adaptation with electronic monitoring of compliance with spectacle wearing using the Occlusion Dose Monitor. VA was assessed before and after this period. If amblyopia persisted, children were randomized to the (A) patching group (2 hr/day) or the (B) dichoptic action video gaming group for 24 weeks. Gaming sessions were conducted at the out-patient clinic on a weekly basis for 1 hour under direct supervision. Contrast- and alignment settings for the dichoptic video game were adjusted subjectively.
Results :
So far, 85 children were recruited, 2 were excluded and 26 refused participation after explaining the nature and purpose of the study. Reasons for refusal were finding the game therapy too time-consuming and logistically challenging (N=19); not interested in participating in research (N=5), distrusting (N=1) or frightened by the game (N=1). Fifty-seven children entered the refractive adaptation period with mean VA at start 0.53±0.39 logMAR in the amblyopic eye (AE) and 0.18±0.21 logMAR in the fellow eye (FE). After 16 weeks it was 0.28±0.26 logMAR in the AE and 0.07±0.13 logMAR in the FE. Mean compliance with spectacle wearing was 71%±18%. After the refractive adaption period 23 children (40%) were sufficiently treated, resulting in 34 children eligible for randomization. So far, there were significantly more dropouts in the gaming group compared with the patching group (N=8 vs N=3; p=0.04). Reasons for drop-out in the patching group were: moved abroad (N=1) and logistic challenges (N=2); in the gaming group: difficulties with the game settings, either because of age (N=3) or language (N=2), logistic challenges (N=2) and loss of interest (N=1).
Conclusions :
A third refused participation mainly due to time and logistic challenges. Furthermore, 40% was sufficiently treated with spectacles alone, improving VA in the AE with 2.6 logMAR lines. A significantly higher drop-out rate was seen in the gaming group.
This is a 2020 ARVO Annual Meeting abstract.