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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Jaeb Center for Health Research

119 total trials

What the finished NCT00091923 record still lists

NCT00091923 is an interventional study that assigns participants to a tested intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 24 other Amblyopia trials with a reported enrollment target (74% higher).

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 a single indexed study location in 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.

Similar trials for Amblyopia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00091923's enrollment target sits among peer trials

268 4th of 24 higher than 21 of 24 other Amblyopia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Amblyopia 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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Source: ClinicalTrials.gov NCT00091923, the US trial registry maintained by the National Library of Medicine. NCT00091923 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.