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NCT00944710 · ClinicalTrials.gov registry record · Phase 3

Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

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

Completed
Registry status
Phase 3
Development phase
73
Enrollment target
2
Study locations

NCT00944710: Completed Phase 3 study of Amblyopia, sponsored by Jaeb Center for Health Research.

NCT00944710 is a Phase 3 study of Amblyopia that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 73 participants, below the 163-participant average among 24 other Amblyopia trials with a reported enrollment target (55% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00944710, a Phase 3 study of Amblyopia, has completed, sponsored by Jaeb Center for Health Research.

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

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.

Primary Outcome

The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol.

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

FieldValue
Enrollment Target 73 participants
Start Date 2009-08
Est. Completion 2013-11
Phase Phase 3
Jaeb Center for Health Research

119 total trials

What the finished NCT00944710 record still lists

NCT00944710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 163-participant average among 24 other Amblyopia trials with a reported enrollment target (55% lower).

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.

NCT00944710 reports a single indexed study location in California, North Carolina.

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.

What interventions are being tested in trial NCT00944710?

The interventions under investigation include: Atropine (DRUG), Plano lens (DEVICE).

Who is sponsoring clinical trial NCT00944710?

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

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.

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 NCT00944710's enrollment target sits among peer trials

73 16th of 24 higher than 9 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 NCT00944710, the US trial registry maintained by the National Library of Medicine. NCT00944710 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.