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Comparing two methods of treating amblyopia in children

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

PHASE3 · Jaeb Center for Health Research · NCT04378790

This study is testing which treatment method works better for kids with amblyopia by comparing wearing glasses and patching at the same time versus wearing glasses first and then patching if needed.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment544 (estimated)
Ages3 Years to 13 Years
SexAll
SponsorJaeb Center for Health Research (other)
Locations68 sites (Birmingham, Alabama and 67 other locations)
Trial IDNCT04378790 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of two treatment approaches for amblyopia in children aged 3 to under 13 years. Participants will be randomly assigned to receive either simultaneous treatment with spectacles and patching or sequential treatment starting with spectacles followed by patching if necessary. The study will monitor visual acuity outcomes over a period of 56 weeks through regular follow-up visits. The goal is to determine which method yields better visual outcomes for children with amblyopia associated with anisometropia or strabismus.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 to under 13 years diagnosed with amblyopia due to anisometropia, strabismus, or both.

Not a fit: Patients who do not have amblyopia or are outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment strategy for improving vision in children with amblyopia.

How similar studies have performed: Previous studies have explored various treatment methods for amblyopia, but this specific comparison of simultaneous versus sequential patching is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age 3 to \<13 years at the time of randomization
2. Amblyopia associated with anisometropia, strabismus, or both

   o 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
3. No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
4. 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:

   1. Full correction of anisometropia
   2. Full correction of astigmatism with the same axis found by the cycloplegic refraction
   3. Full correction of any myopia
   4. Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.
5. 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 o 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).
6. Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.
7. Parent understands the protocol and is willing to accept randomization.
8. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
9. Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.

Exclusion Criteria:

1. Myopia greater than -6.00 D spherical equivalent in either eye.
2. Previous intraocular or refractive surgery.
3. Planned strabismus surgery in the next 56 weeks.
4. Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
5. Previous spectacle or contact lens wear for more than 24 hours.
6. Parent and participant willing to forego option of contact lens wear for the duration of the study.
7. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above VA criteria are met).
8. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or attention deficit hyperactivity disorder (ADHD) are not excluded.
9. Known allergy to adhesive patches.
10. Known allergy to silicone.

Where this trial is running

Birmingham, Alabama and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Amblyopia, patching, glasses, spectacles, simultaneous, sequential

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.