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A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Study acronym: ATS22
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Site contacts updated at 1 of 68 sitesv28
  2. Start date: Jan 1, 2021 to Dec 8, 2020
    • Site contacts updated at 11 of 68 sites
    v27
  3. Study sites: 66 to 68
    • Primary and study completion dates: May 31, 2028 to May 1, 2028
    • Start date: Dec 8, 2020 to Jan 1, 2021
    v26
  4. Re-verified, no change to tracked fieldsv25
  5. Study sites revised (66)v24
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites revised (66)v23
  2. Study sites: 52 to 66v22
  3. Phase: Not applicable to Phase 3
    • Primary and study completion dates: Jun 2025 to May 31, 2028
    v21
  4. 2 versions Re-verified since Nov 27, 2023, no change to tracked fieldsv19-v20
  5. Primary and study completion dates: Jun 2023 to Jun 2025v18
  6. 4 versions Re-verified since Feb 16, 2022, no change to tracked fieldsv14-v17
  7. Primary and study completion dates: Sep 2022 to Jun 2023v13
  8. 4 versions Re-verified since Jun 4, 2021, no change to tracked fieldsv9-v12
  9. Study sites: 2 to 52v8
  10. Re-verified, no change to tracked fieldsv7
  11. Start date changed from estimate of Nov 2020 to Dec 8, 2020v6
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2020 to Nov 2020
    • Site details revised at 2 of 2 sites
    v5
  13. Start date: Sep 2020 to Oct 2020v4
  14. Re-verified, no change to tracked fieldsv3
  15. Start date: Aug 2020 to Sep 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \<13 years of age.
Trial Details
NCT Number NCT04378790
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 544 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov