Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524882
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATS24
Brief Summary:
Participants eligible for the study will be randomly allocated 111 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None