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NCT00091923 · ClinicalTrials.gov registry record · Phase 3

Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children

A Phase 3 study of Amblyopia, sponsored by Jaeb Center for Health Research.

Completed
Registry status
Phase 3
Development phase
268
Enrollment target
2
Study locations

NCT00091923 is a Phase 3 study of Amblyopia that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 268 participants, above the 154-participant average among 24 other Amblyopia trials with a reported enrollment target (74% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT00091923, a Phase 3 study of Amblyopia, has completed, sponsored by Jaeb Center for Health Research.

COMPLETED
Registry status
Phase 3
Development phase
268 participants
Enrollment target
2
Study locations

Study Summary

The objectives of the Spectacle Phase are: * In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine 1. the incidence of resolution of amblyopia with spectacle correction alone and 2. the time course of visual acuity improvement with spectacle correction alone. * In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial. The objectives of the Randomized Trial are: * To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400). * To determine the maximal improvement and time course of improvement with this patching treatment regimen.

Conditions Studied

Interventions

  • DEVICE Spectacles
  • DEVICE Eye patch

Study Locations (2)

California

  • Southern California College of Optometry - Fullerton

North Carolina

  • Duke University Eye Center - Durham

Trial Details

FieldValue
Enrollment Target 268 participants
Start Date 2004-02
Est. Completion 2005-12
Phase Phase 3

Sponsor

Jaeb Center for Health Research

119 total trials

What the Registry Record Tells You About NCT00091923

The ClinicalTrials.gov registry entry for NCT00091923 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 154-participant average among 24 other Amblyopia trials with a reported enrollment target (74% higher). The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Amblyopia appearing as the primary indexed condition, and to 2 interventions - of which Spectacles is the first listed.

NCT00091923 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00091923 about?

NCT00091923 is a clinical study titled "Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children". The objectives of the Spectacle Phase are: * In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine 1. the incidence of resolution of amblyopia with spectacle correction alone and 2. the tim...

What is the current status of trial NCT00091923?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 268 participants. The study started on 2004-02. Estimated completion is 2005-12.

What conditions does trial NCT00091923 study?

This clinical trial studies the following conditions: Amblyopia.

What interventions are being tested in trial NCT00091923?

The interventions under investigation include: Spectacles (DEVICE), Eye patch (DEVICE).

Who is sponsoring clinical trial NCT00091923?

This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00091923 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.