Purpose: We sought to describe the change in ocular alignment at 2 years after treatment of amblyopia in children younger than 7 years of age at enrollment.
Methods: A randomized clinical trial of patching versus atropine for 6 months followed by standard clinical care for 18 months was conducted in 357 children with anisometropic, strabismic, or combined amblyopia (20/40-20/100) whose ages ranged from 3 to younger than 7 years at enrollment. Ocular alignment was evaluated at enrollment and after 2 years of follow-up.
Results: At enrollment when tested at distance fixation, 161 (45%) children were orthotropic, 91 (25%) had a microtropia (1-8 Delta), and 105 (29%) had a heterotropia >8 Delta. Of the 161 patients with no strabismus, similar proportions of patients initially assigned to the patching and atropine groups developed new strabismus by 2 years (18% vs. 16%, P = 0.84). Of these cases of new strabismus, only 2 patients in the patching group and 3 patients in the atropine group developed a deviation that was greater than 8 Delta. Microtropia at enrollment progressed to a deviation greater than 8 Delta with similar frequency in both treatment groups (13% vs. 15%, P = 1.00). Of the 105 patients with strabismus greater than 8 Delta at enrollment, 13% of those in the patching group and 16% of those in the atropine group improved to orthotropia without strabismus surgery. Strabismus surgery was performed in 32 patients during the 2-year study period.
Conclusions: Patients who had amblyopia treatment with patching or atropine for 6 months followed by standard clinical care were found to have similar rates of deterioration and improvement of ocular alignment. When parents begin amblyopia treatment for children without strabismus, they should be warned of the possibility of development of strabismus, although it is most often a small angle deviation. Strabismus resolved after amblyopia therapy in some cases.