A randomized trial comparing Bangerter filters and patching for the treatment of moderate amblyopia in children.
OBJECTIVE
To determine whether visual acuity improvement with Bangerter filters is similar to improvement with patching as initial therapy for children with moderate amblyopia.


METHODS
Randomized, clinical trial.


METHODS
We enrolled 186 children, 3 to <10 years old, with moderate amblyopia (20/40-20/80).


METHODS
Children were randomly assigned to receive either daily patching or to use a Bangerter filter on the spectacle lens in front of the fellow eye. Study visits were scheduled at 6, 12, 18, and 24 weeks.


METHODS
Visual acuity in amblyopic eyes at 24 weeks.


RESULTS
At 24 weeks, amblyopic eye improvement averaged 1.9 lines in the Bangerter group and 2.3 lines in the patching group (difference in mean visual acuities between groups adjusted for baseline acuity = 0.38 line). The upper limit of a 1-sided 95% confidence interval was 0.76 line, which slightly exceeded a prespecified noninferiority limit of <0.75 line. Similar percentages of subjects in each group improved > or =3 lines (Bangerter group 38% vs patching group 35%; P = 0.61) or had > or =20/25 amblyopic eye acuity (36% vs 31%, respectively; P = 0.86). There was a lower treatment burden in the Bangerter group as measured with the Amblyopia Treatment Index. With Bangerter filters, neither a fixation switch to the amblyopic eye nor induced blurring in the fellow eye to worse than that of the amblyopic eye was required for visual acuity improvement.


CONCLUSIONS
Because the average difference in visual acuity improvement between Bangerter filters and patching was less than half a line, and there was lower burden of treatment on the child and family, Bangerter filter treatment is a reasonable option to consider for initial treatment of moderate amblyopia.
Jaeb Center for Health Research, Tampa, FL 33647, USA
Rutstein
Robert P
RP
Quinn
Graham E
GE
Lazar
Elizabeth L
EL
Beck
Roy W
RW
Bonsall
Dean J
DJ
Cotter
Susan A
SA
Crouch
Eric R
ER
Holmes
Jonathan M
JM
Hoover
Darren L
DL
Leske
David A
DA
Lorenzana
Ingryd J
IJ
Repka
Michael X
MX
Suh
Donny W
DW
D000550:Amblyopia / Q000503:physiopathology / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D005139:Eyeglasses; D005260:Female; D006801:Humans; D008297:Male; D009779:Occlusive Dressings; D012683:Sensory Deprivation; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology*