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NCT00945100 · ClinicalTrials.gov registry record · Phase 3
Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 169
- Enrollment target
NCT00945100: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT00945100 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00945100, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 169 participants
- Enrollment target
Study Summary
This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
Primary Outcome
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol.
Interventions
- DEVICE Eye Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT00945100 record still lists
NCT00945100 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Eye Patch is the first listed.
NCT00945100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00945100 about?
NCT00945100 is a clinical study titled "Increasing Patching for Amblyopia in Children 3 to < 8 Years Old". This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye w...
What is the current status of trial NCT00945100?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2009-08. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00945100?
The interventions under investigation include: Eye Patch (DEVICE).
Who is sponsoring clinical trial NCT00945100?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00945100's enrollment target sits among peer trials
169 1459th of 2000 higher than 542 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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