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Original Investigation
July 15, 2021

Effect of Combined Atropine and Patching vs Patching Alone for Treatment of Severe Amblyopia in Children Aged 3 to 12 Years: A Randomized Clinical Trial

Author Affiliations
  • 1Eye Institute, Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China
  • 2NHC Key Laboratory of Myopia (Fudan University), Shanghai, China
  • 3Shanghai Key Laboratory of Visual Impairment and Restoration, Shanghai, China
  • 4Department of Ophthalmology, Shanghai Children’s Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China
JAMA Ophthalmol. Published online July 15, 2021. doi:10.1001/jamaophthalmol.2021.2413
Visual Abstract. Effect of combined atropine and patching vs patching alone for treatment of severe amblyopia in children aged 3 to 12 years
Effect of combined atropine and patching vs patching alone for treatment of severe amblyopia in children aged 3 to 12 years
Key Points

Question  Is combined atropine and patching therapy (CAPT) more efficacious than patching alone for children aged 3 to 12 years with severe amblyopia?

Findings  In this randomized clinical trial of 108 children, there was substantial improvement in both groups from baseline to 6 months and greater in the CAPT group.

Meaning  While the mean CAPT group amblyopic eye visual acuity improvement was superior to the patching group, the differences were relatively small and the clinical relevance of this difference cannot be determined by this trial.

Abstract

Importance  Patching is often less effective for severe amblyopia because of poor adherence. For the treatment of severe amblyopia, although combined atropine and patching therapy (CAPT) has been found to be efficacious, it is currently unknown whether CAPT is more efficacious than patching alone.

Objective  To compare the efficacy of CAPT vs patching alone in children aged 3 to 12 years with severe amblyopia.

Design, Setting, and Participants  This single-center randomized clinical trial was conducted from November 2018 to May 2020. The visual acuity (VA) examiner was masked to the treatment groups. The follow-up visits were at 3 months and 6 months. Participants aged 3 to 12 years with severe amblyopia (20/100 to 20/500) resulting from strabismus, anisometropia, or both were randomly assigned to CAPT or patching therapy.

Interventions  CAPT or patching alone for 6 months.

Main Outcomes and Measures  Change of the amblyopic eye VA from baseline to 6 months.

Results  Among 108 participants, the mean (SD) age was 5.2 (1.8) years, and 54 (50%) were female. Overall, 53 participants (49%) were randomized to CAPT and 55 (51%) were randomized to patching therapy. At baseline, the mean (SD) amblyopic eye VA was 0.95 (0.22) logMAR (approximately 20/200 [2.2 lines]). At 6 months, the CAPT group’s mean improvement in amblyopic eye VA was 0.72 logMAR (7.2 lines) compared with 0.58 logMAR (5.8 lines) in the patching alone group (difference, 0.14 logMAR [1.4 lines] greater in the CAPT group; 95% CI, 0.05-0.22 logMAR [0.5-2.2 lines]; P = .002). The amblyopic eye VA improvement in the CAPT group also was greater than that in the patching alone group at 3 months (difference in the means, 0.13 logMAR [1.3 lines]; 95% CI, 0.04-0.22 logMAR [0.4-2.2 lines]; P = .004). No participants were withdrawn because of adverse effects.

Conclusions and Relevance  CAPT resulted in more mean improvement of amblyopic eye VA than patching alone among participants enrolled in this trial, although the clinical relevance of this relatively small VA difference cannot be determined from this trial.

Trial Registration  Chinese Clinical Trial Registry Identifier: ChiCTR1800018663

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