Purpose: To assess the course of the response to atropine treatment of moderate amblyopia and to assess factors predictive of the treatment response in children 3 years old to younger than 7 years old.
Design: Multicenter, randomized clinical trial comparing atropine and patching (one of the amblyopia treatment studies).
Methods: A total of 195 children 3 years old to younger than 7 years of age with amblyopia in the range of 20/40 to 20/100 from the atropine treatment arm of this trial were enrolled and included in this analysis. At baseline, daily topical atropine was prescribed for the sound eye. During follow-up, a plano spectacle lens was prescribed for the sound eye for patients whose amblyopia had not been successfully treated with atropine alone. Follow-up examinations were performed at 5 weeks, 16 weeks, and 6 months. The primary outcome measure was visual acuity in the amblyopic eye at 6 months.
Results: Mean visual acuity improved from baseline by 1.3 lines after 5 weeks of treatment, by 2.4 lines after 16 weeks, and by 2.8 lines at 6 months. Visual acuity of 20/30 or better and/or 3 or more lines of improvement from baseline was achieved by 75% of the patients. Improvement occurred over the entire range of baseline acuities (20/40 to 20/100) and was not related to patient age (P =.36). Among the 134 patients improving 3 or more lines from baseline, 7% achieved their maximum improvement by 5 weeks and 46% by 16 weeks. Among the 55 patients who did not respond adequately to atropine alone and were prescribed a plano lens for the sound eye, the mean improvement before the use of the plano lens was 1.0 lines, compared with 1.6 lines after prescribing the plano lens (P =.11). None of the demographic or clinical factors assessed was predictive of the response to treatment. A shift in fixation preference at/near from the atropinized sound eye to the amblyopic eye was not required for the amblyopic eye to improve; amblyopic eye acuity improved 3 or more lines in 29 (60%) of the 48 patients who were found to be using the atropinized sound eye on fixation preference testing. A 2 or more line decrease in sound eye visual acuity occurred more frequently when a plano lens was prescribed in addition to atropine (7 of 43, 16%) compared with treatment with atropine alone (4 of 123, 3%; P =.01).
Conclusions: A beneficial effect of atropine is present throughout the age range of 3 years old to younger than 7 years old, and with an acuity range of 20/40 to 20/100. A shift in near fixation to the amblyopic eye is not essential for atropine to be effective in all cases. Sound eye acuity should be monitored when a plano spectacle lens is prescribed for the sound eye to augment the treatment effect of atropine.