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NCT00315302 · ClinicalTrials.gov registry record · Phase 3
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
NCT00315302: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT00315302 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315302, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
Study Summary
The purpose of the study is: * To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old. * To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.
Primary Outcome
Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/4
Interventions
- DRUG Atropine
- DEVICE Plano Lens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00315302 record still lists
NCT00315302 is an interventional study that assigns participants to a tested intervention. The registered 240 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 (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Atropine is the first listed.
NCT00315302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00315302 about?
NCT00315302 is a clinical study titled "Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old". The purpose of the study is: * To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old. * To provide data on the response of severe amblyop...
What is the current status of trial NCT00315302?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2005-02. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00315302?
The interventions under investigation include: Atropine (DRUG), Plano Lens (DEVICE).
Who is sponsoring clinical trial NCT00315302?
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 NCT00315302's enrollment target sits among peer trials
240 1273rd of 2000 higher than 710 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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