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Amblyopia (Lazy Eye) Treatment Study
NCT00001864 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to compare the results of two standard treatments for amblyopia in order to find out if one is more effective than the other. Amblyopia, which develops in childhood, is also called "lazy eye," because one eye is not being used properly. The brain favors the other eye for some reason, such as crossing or turning out of the eyes, and vision in the weak eye is reduced. Amblyopia is treated by forcing the child to use the weak eye. There are two ways to do this: 1) a patch placed over the "good" eye forces the child to use the weak eye; or 2) an eye drop placed in the "good" eye once a day to blur vision in that eye makes the child rely on the weak eye. The success rates with both of these methods have been reported to be about the same; this study will try to identify if one is more effective than the other. Children will be randomly assigned by computer to one of the following two treatment methods: Patch The child initially will wear a patch over the "good" eye for 8 to 12 hours every day. If vision in the weak eye improves, the patching time will be decreased. If vision remains good after 3 months, the patching will be stopped, unless the child's doctor believes treatment should continue. If vision in the weak eye does not improve, the patching time will be increased. Eye Drops The child will be given one drop per day of atropine in the "good" eye. If vision in the weak eye improves, the drops will be given less often. If the vision remains good after 3 months, the drops will be stopped, unless the child's doctor believes treatment should continue. If the initial daily drop does not improve the vision in the weak eye, the child's eyeglasses may be changed to try to further blur the vision in the "good" eye. After 6 months, treatment may be stopped if it has not been successful. If treatment has been successful after 6 months, it may be continued at a reduced amount or stopped. Follow-up visits will be scheduled every 4 weeks for
Conditions Studied
Interventions
- DRUG Atropine
- DEVICE Patch
Study Locations (1)
Maryland
- National Eye Institute (NEI) — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 1999-05 |
| Est. Completion | 2001-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001864
The ClinicalTrials.gov registry entry for NCT00001864 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 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 214 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, 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: NCT00001864 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. 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 NCT00001864 about?
NCT00001864 is a clinical study titled "Amblyopia (Lazy Eye) Treatment Study". The purpose of this study is to compare the results of two standard treatments for amblyopia in order to find out if one is more effective than the other. Amblyopia, which develops in childhood, is also called "lazy eye," because one eye is not being used properly. The brain favors the other eye for...
What is the current status of trial NCT00001864?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 1999-05. Estimated completion is 2001-11.
What conditions does trial NCT00001864 study?
This clinical trial studies the following conditions: Amblyopia, Strabismus, Anisometropia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00001864?
The interventions under investigation include: Atropine (DRUG), Patch (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00001864?
This trial is sponsored by National Eye Institute (NEI), which has 214 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00001864 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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