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Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

Study acronym: ATS23
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 70 to 73v11
  2. Primary completion date: Dec 1, 2026 to Jul 1, 2027
    • Study completion date: May 1, 2027 to Jan 1, 2028
    • Start date: Jul 11, 2024 to Jul 1, 2024
    v10
  3. Study sites: 64 to 70v9
  4. Study sites: 52 to 64v8
  5. Study sites revised (52)v7
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  1. Study sites: 26 to 52v6
  2. Study sites revised (26)v5
  3. Phase: Not applicable to Phase 3v4
  4. Study sites: 5 to 26v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of May 1, 2024 to Jul 11, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.
Trial Details
NCT Number NCT06380517
Lead Sponsor Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
Conditions
(from sponsor)		 Amblyopia
Related terms Amblyopia
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov