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Actively Recruiting

Phase 3
Age: 3Years - 13Years
All Genders
ID04378790

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

Led by Jaeb Center for Health Research · Updated on 2026-02-11

544

Participants Needed

68

Research Sites

N/A

Total Duration

On this page

Sponsors

J

Jaeb Center for Health Research

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.

CONDITIONS

Brief Title

A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Who Can Participate

Age: 3Years - 13Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 3 to <13 years at the time of randomization
  • Amblyopia caused by anisometropia, strabismus, or both
  • For strabismic amblyopia: presence or history of eye misalignment that may have caused amblyopia
  • For anisometropia: at least 1.00 D difference in spherical equivalent or 1.50 D difference in astigmatism between eyes
  • For combined amblyopia: criteria for strabismus plus anisometropia
  • No previous amblyopia treatment, including no more than 24 hours of wearing glasses
  • Investigator plans to prescribe full spectacle correction based on recent cycloplegic refraction
  • Visual acuity in amblyopic eye between 20/40 and 20/200; age-normal vision in fellow eye
  • Parent understands and agrees to study procedures and randomization
  • Parent has phone access and agrees to study contact
  • No plans to relocate outside study area during 56-week study period
Not Eligible

You will not qualify if you...

  • Myopia worse than -6.00 D spherical equivalent in either eye
  • Previous eye surgery affecting vision
  • Planned strabismus surgery within 56 weeks
  • Any prior amblyopia treatment such as patching, atropine, vision therapy, or binocular treatment
  • More than 24 hours of prior spectacle or contact lens wear
  • Willingness to avoid contact lenses during the study
  • Eye conditions that reduce vision other than amblyopia
  • Severe developmental delays interfering with treatment or assessment
  • Known allergy to adhesive patches or silicone materials

Research Team

R

Raymond T Kraker, MSPH

B

Brooke P Fimbel

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