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NCT04378790 · ClinicalTrials.gov registry record · Phase 3
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
A Phase 3 study of Amblyopia, sponsored by Jaeb Center for Health Research.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 544
- Enrollment target
- 20
- Study locations
NCT04378790: Recruiting Phase 3 study of Amblyopia, sponsored by Jaeb Center for Health Research.
NCT04378790 is a Phase 3 study of Amblyopia that is actively recruiting participants, run by Jaeb Center for Health Research. The registered enrollment target is 544 participants, above the 143-participant average among 24 other Amblyopia trials with a reported enrollment target (280% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04378790, a Phase 3 study of Amblyopia, is actively recruiting participants, sponsored by Jaeb Center for Health Research.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 544 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
1. Amblyopic eye VA (calculated as mean of test and retest) at the last visit that was the basis for a "stable resolved" or "stable residual" determination (in the sequential group, stable residual amblyopia criteria can be reached only after patching has been instituted); or 2. 56-week visit amblyopic-eye VA (calculated as mean of test and retest) in those completing a 56-week visit without ever meeting criteria for "stable resolved" or "stable residual" amblyopia (if retest missing at 56 weeks
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
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2028-05-01 |
| Phase | Phase 3 |
What NCT04378790 shows while recruiting
NCT04378790 is an interventional study that assigns participants to a tested intervention. The registered 544 participants enrollment target is mid-sized for trials with a published cap, above the 143-participant average among 24 other Amblyopia trials with a reported enrollment target (280% higher).
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.
NCT04378790 names 20 study sites across 7 states, led by California, Arizona, Florida.
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.
What interventions are being tested in trial NCT04378790?
The interventions under investigation include: Patching (OTHER), Glasses (OTHER).
Who is sponsoring clinical trial NCT04378790?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Amblyopia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04378790's enrollment target sits among peer trials
544 1st of 24 higher than 24 of 24 other Amblyopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amblyopia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
RECRUITING · Phase 3
-
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
RECRUITING · Phase 3
-
Amblyopia (Lazy Eye) Treatment Study
COMPLETED · Phase 3
-
Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children
COMPLETED · Phase 3
-
Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
COMPLETED · Phase 3
-
Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia
COMPLETED · Phase 3
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