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Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial

  • Pediatrics
  • Published:
Graefe's Archive for Clinical and Experimental Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To investigate efficacy of over-glasses patching treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.

Methods

In a randomized multi-center controlled clinical trial, 107 children aged 3–7 years with moderate amblyopia (visual acuity in the range of 20/40 to 20/100) were included to receive treatment with either an adhesive skin patch or a fabric over-glasses patch. The patients were prescribed 2 h of patching per day for the sound eye. Best-corrected visual acuity (BCVA) was investigated and ATI questionnaires were collected from parents at 5 weeks and 17 weeks after the initiation of treatment. ATI identifies barriers and problems associated with amblyopia treatment. We compared the changes of visual acuity of amblyopic eyes and ATI scores in two groups.

Results

At 17 weeks, the mean visual acuity of the amblyopic eye using Snellen chart improved 3.2 lines in the adhesive patching group and 2.7 lines for an over-glasses patching method that fit over eyeglasses (p = 0.345). A similar proportion of subjects in each group had improvement of ≥ 2 lines (adhesive patching group 67% vs over-glasses patching group 67%, p = 0.372). There was also no difference in treatment burden in each group as measured with the Amblyopia Treatment Index. The only item to demonstrate a significant difference between groups was that related to “Treatment makes the eye or eyelids red” (mean 4.0 ± 1.1 vs 3.0 ± 1.0 at 17 weeks, p = 0.001, for adhesive vs over-glasses patch).

Conclusions

Over-glasses patching treatment is a useful option for amblyopia treatment when the patients suffer from adverse effects of using adhesive skin patching.

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Author information

Authors and Affiliations

  1. Department of Ophthalmology, School of Medicine, Gyeongsang National University, Gyeongsang National University Changwon Hospital, Changwon, South Korea

    Su Jin Kim

  2. Department of Ophthalmology, School of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, South Korea

    Hyeshin Jeon, Jae Ho Jung & Hee Young Choi

  3. Clinical Trial Center, Dong-A University College of Medicine and Hospital, Busan, South Korea

    Kwang Min Lee

Authors
  1. Su Jin Kim
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  2. Hyeshin Jeon
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  3. Jae Ho Jung
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  4. Kwang Min Lee
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  5. Hee Young Choi
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Corresponding author

Correspondence to Hee Young Choi.

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Conflict of interest

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest, or other equity interest, or non-financial interest in the subject matter or materials discussed in this manuscript.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board (IRB) of the participating centers and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Trial Registration: Efficacy of Over-glasses Patch Treatment for Amblyopia in Children: OPTA Study (OPTA), https://clinicaltrials.gov/ct2/show/NCT03080285?term=NCT03080285&rank=1, NCT03080285

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Kim, S.J., Jeon, H., Jung, J.H. et al. Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. Graefes Arch Clin Exp Ophthalmol 256, 429–437 (2018). https://doi.org/10.1007/s00417-017-3851-2

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  • DOI: https://doi.org/10.1007/s00417-017-3851-2

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