A Study Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles Plus Patching for Amblyopia in Children 3 to < 13 Years Old


About this study

The purpose of this study is to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone, followed by patching (if needed), for previously untreated amblyopia in children 3 to < 13 years of age.



Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 3 to < 13 years at the time of randomization.
  • Amblyopia associated with anisometropia, strabismus, or both.
  • Criteria for strabismic amblyopia: At least one of the following must be met: 
    • Presence of a heterotropia on examination at distance or near fixation (with or without optical correction);
    • Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).
  • Criteria for anisometropia: At least one of the following criteria must be met: 
    • ≥ 1.00 D difference between eyes in spherical equivalent (SE); 
    • ≥ 1.50 D difference in astigmatism between corresponding meridians in the two eyes.
  • Criteria for combined-mechanism amblyopia: Both of the following criteria must be met: 
    • Criteria for strabismus are met (see above);
    • ≥ 1.00 D difference between eyes in spherical equivalent OR ≥ 1.50 D difference in astigmatism between corresponding meridians in the two eyes. 
  • No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
  • Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days: 
    • Full correction of spherical and cylindrical anisometropia;
    • Full correction of astigmatism with the same axis found by the cycloplegic refraction;
    • Allow symmetric reduction of sphere up to 1.50, prescribing such that the most hyperopic meridian is not rendered myopic, in the non-amblyopic eye at baseline;
    • Allow symmetric addition of only -0.25 sphere for participants with plano sphere, spherical myopia, simple or compound myopic astigmatism in the non-amblyopic eye at baseline.
  • At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator’s routine method as follows:
    • VA in the amblyopic eye 20/40 to 20/200 inclusive;
    • Age-normal VA in the fellow eye:40,41;
    • 3 years: 0.4 logMAR (20/50) or better; 
    • 4 years: 0.3 logMAR (20/40) or better;
    • 5-6 years: 0.2 logMAR (20/32) or better;
    • 7-12 years: 0.12 logMAR (78 letters) or better; 
    • Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters;
    • When participants return for the Spectacle Baseline / Randomization Visit with their new spectacles, they will need to meet the same criteria as above using the ATS HOTV or E-ETDRS protocol after wearing the new spectacles for at least 10 minutes (based upon the mean of a test and retest of VA in those new spectacles).
  • Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.
  • Parent and participant willing to forego option of contact lens wear for the duration of the study. 
  • Parent understands the protocol and is willing to accept randomization. 
  • Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff. 
  • Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.

Exclusion Criteria:

  • Previous spectacle wear.
  • Previous treatment for amblyopia.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Erick Bothun, M.D.

Open for enrollment

Contact information:

Suzanne Wernimont CCRP

(507) 266-4326


More information


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