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Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
NCT00944710 · View on ClinicalTrials.gov ↗
Study Summary
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but 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 weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
Conditions Studied
Interventions
- DRUG Atropine
- DEVICE Plano lens
Study Locations (2)
California
- Southern California College of Optometry — Fullerton
North Carolina
- Duke University Eye Center — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00944710
The ClinicalTrials.gov registry entry for NCT00944710 describes a study currently listed as completed. 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 73 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 Atropine 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: NCT00944710 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, North Carolina. 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 NCT00944710 about?
NCT00944710 is a clinical study titled "Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old". This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but 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-i...
What is the current status of trial NCT00944710?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 73 participants. The study started on 2009-08. Estimated completion is 2013-11.
What conditions does trial NCT00944710 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 NCT00944710?
The interventions under investigation include: Atropine (DRUG), Plano lens (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00944710?
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 NCT00944710 being conducted?
This trial has 2 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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