PURPOSE: To compare the efficacy and sensory outcome of pharmacologic and optical penalization in the treatment of moderate to mild amblyopia. DESIGN: Randomized clinical trial. METHODS: In an institutional setting, two- to 10-year-old children with strabismic or anisometropic amblyopia (visual acuity in the amblyopic eye at least 20/60) who were cooperative to measure visual acuity using the logarithm of the minimum angle of resolution (logMAR) crowded Glasgow acuity cards were randomized into two groups of therapy (n = 35 in each group), 1% atropine, and optical penalization with positive lenses, after stratification by cause of amblyopia. Visual acuity was tested by the logMAR crowded Glasgow acuity cards, after retinoscopic refraction, and deviation angle were measured by the simultaneous prism and cover or Krimsky test. Stereoacuity was determined using the Titmus fly test and Randot preschool or Randot circles stereoacuity test. Change in visual acuity of the amblyopic
eye and in interocular difference of visual acuity after six months of amblyopia therapy was the main outcome measure; stereoacuity at six months of therapy was a secondary outcome measure. RESULTS: Thirty-one and 32 children completed the outcome examination in the atropine and optical penalization group, respectively. Average improvement in visual acuity of the amblyopic eye was larger in the atropine than in the optical penalization group (3.4 and 1.8 logMAR lines, respectively), as well as average improvement in interocular difference of visual acuity (2.8 and 1.3 logMAR lines, respectively). Better stereoacuity, but nonsignificantly different, was detected in the atropine group. CONCLUSIONS: Atropine penalization may be considered more effective than optical penalization with positive lenses.