Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06524882 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Study acronym: ATS24
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 53 to 58v12
  2. Start date: Feb 21, 2025 to Oct 22, 2024
    • Site contacts updated at 17 of 53 sites
    v11
  3. Start date: Oct 22, 2024 to Feb 21, 2025
    • Study sites: 52 to 53
    • Primary completion date: Feb 1, 2027 to Jul 1, 2027
    • Study completion date: Jun 1, 2027 to Nov 1, 2027
    v10
  4. Study sites: 45 to 52v9
  5. Study sites: 41 to 45v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 30 to 41v7
  2. Study sites: 3 to 30v6
  3. Phase: Not applicable to Phase 3v5
  4. Start date changed from estimate of Dec 1, 2024 to Oct 22, 2024v4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date: Oct 1, 2024 to Dec 1, 2024
    • Study sites: 0 to 3
    • Primary completion date: Jul 1, 2027 to Feb 1, 2027
    • Study completion date: Jul 1, 2027 to Jun 1, 2027
  6. Start date: Aug 1, 2024 to Oct 1, 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks.
Trial Details
NCT Number NCT06524882
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 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov