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RECRUITING Phase 3

A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

NCT04378790 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • OTHER Patching
  • OTHER Glasses

Study Locations (20)

California

  • Univ. of California- Berkeley — Berkeley
  • Marshall B. Ketchum University — Fullerton
  • Univ of California, Irvine- Gavin Herbert Eye Institute — Irvine
  • Loma Linda University Health Care, Dept. of Ophthalmology — Loma Linda
  • Children's Hospital of Los Angeles (CHLA) — Los Angeles
  • Stanford University — Palo Alto
  • Western University College of Optometry — Pomona
  • University of California, Davis — Sacramento
  • University of California San Francisco Department of Ophthalmology — San Francisco

Arizona

  • Midwestern University Eye Institute — Glendale
  • Arizonia Pediatric Eye Specialists — Phoenix
  • University of Arizona — Tucson

Florida

  • Nova Southeastern University College of Optometry, The Eye Institute — Fort Lauderdale
  • Nemours Children's Clinic — Jacksonville
  • University of South Florida (USF) Eye — Tampa

Alabama

  • UAB Pediatric Eye Care; Birmingham Health Care — Birmingham
  • University of Alabama at Birmingham — Birmingham

Connecticut

  • Eye Physicians & Surgeons, PC — Milford

Idaho

  • St Luke's Hospital — Boise

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago

Trial Details

FieldValue
Enrollment Target 544 participants
Start Date 2020-12-08
Est. Completion 2028-05-01
Phase Phase 3

Sponsor

Jaeb Center for Health Research

134 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04378790

The ClinicalTrials.gov registry entry for NCT04378790 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 544 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Amblyopia appearing as the primary indexed condition, and to 2 interventions — of which Patching is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04378790 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04378790 about?

NCT04378790 is a clinical study titled "A Randomized Trial to Evaluate Sequential vs Simultaneous Patching". 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.

What is the current status of trial NCT04378790?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 544 participants. The study started on 2020-12-08. Estimated completion is 2028-05-01.

What conditions does trial NCT04378790 study?

This clinical trial studies the following conditions: Amblyopia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04378790?

The interventions under investigation include: Patching (OTHER), Glasses (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04378790?

This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04378790 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial