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Differences between protocol and review The new risk of bias table introduced by the Cochrane Collaboration was used to assess methodological quality of included studies. Post peer review for the manuscript, a decision was made to exclude systemic therapy and therefore the search strategies were amended accordingly and the review process started again with the new search results.

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Background Amblyopia is defined as defective visual acuity in one or both eyes without demonstrable abnormality of the visual pathway, and is not immediately resolved by wearing glasses. Objectives To assess the effectiveness and safety of conventional occlusion versus atropine penalization for amblyopia. Search strategy We searched CENTRAL, MEDLINE, EMBASE, LILACS, the WHO International Clinical Trials Registry Platform, preference lists, science citation index and ongoing trials up to June 2009. Selection criteria We included randomized/quasi‐randomized controlled trials comparing conventional occlusion to atropine penalization for amblyopia. Data collection and analysis Two authors independently screened abstracts and full text articles, abstracted data, and assessed the risk of bias. Main results Three trials with a total of 525 amblyopic eyes were included. One trial was assessed as having a low risk of bias among these three trials, and one was assessed as having a high risk of bias. Evidence from three trials suggests atropine penalization is as effective as conventional occlusion. One trial found similar improvement in vision at six and 24 months. At six months, visual acuity in the amblyopic eye improved from baseline 3.16 lines in the occlusion and 2.84 lines in the atropine group (mean difference 0.034 logMAR; 95% confidence interval (CI) 0.005 to 0.064 logMAR). At 24 months, additional improvement was seen in both groups; but there continued to be no meaningful difference (mean difference 0.01 logMAR; 95% CI −0.02 to 0.04 logMAR). The second trial reported atropine to be more effective than occlusion. At six months, visual acuity improved 1.8 lines in the patching group and 3.4 lines in the atropine penalization group, and was in favor of atropine (mean difference ‐0.16 logMAR; 95% CI ‐0.23 to ‐0.09 logMAR). Different occlusion modalities were used in these two trials. The third trial had inherent methodological flaws and limited inference could be drawn. No difference in ocular alignment, stereo acuity and sound eye visual acuity between occlusion and atropine penalization was found. Although both treatments were well tolerated, compliance was better in atropine. Atropine penalization costs less than conventional occlusion. The results indicate that atropine penalization is as effective as conventional occlusion. Authors' conclusions Both conventional occlusion and atropine penalization produce visual acuity improvement in the amblyopic eye. Atropine penalization appears to be as effective as conventional occlusion, although the magnitude of improvement differed among the three trials. Atropine penalization can be used as first line treatment for amblyopia. Plain Language Summary Treatment of amblyopia (lazy eye) with patching or drops/drug treatment Amblyopia (referred to as lazy eye) is a common childhood condition, and is defined as defective visual acuity in one or both eyes, which is present with no demonstrable abnormality of the visual pathway and is not immediately resolved by wearin...

Occlusion, whilst wearing necessary refractive correction, appears to be more effective than refractive correction alone in the treatment of strabismic amblyopia. Combining occlusion and refractive correction with near activities may be more effective than occlusion and refractive correction alone. Further study of the role of near activities is necessary before a more definitive conclusion can be made. Results of a full trial are expected within the coming year. No RCTs were found that assessed the role of either partial occlusion or optical penalisation to refractive correction for strabismic amblyopia.