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A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

NCT04378790 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2026-02-11

No results posted yet for this study

Summary

A randomized trial 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.

Conditions

  • Amblyopia

Interventions

OTHER

Patching

Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye.

OTHER

Glasses

Eye Glasses are created and worn by patient to improve vision

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Vivian Manh · Seattle Children's Hospital, University of Washington

  • Michael Gray · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2028-05-01
Completion
2028-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378790 on ClinicalTrials.gov